On May 13, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2022 (Press release, Outlook Therapeutics, MAY 13, 2022, View Source [SID1234616059]).

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Recent Corporate Highlights

Successfully submitted a BLA for ONS-5010, an investigational therapy which, if approved, will be branded as LYTENAVA (bevacizumab-vikg), for the treatment of wet age-related macular degeneration (wet AMD);
Expanded commercial team with the appointment of Joel Prieve as Senior Vice President, Commercial Operations, in February 2022; and
Further expanded commercial team with appointment of Alicia Tozier as Senior Vice President, Marketing and Market Access, in March 2022.
"This past quarter was marked by the achievement of the most important milestone to date for Outlook Therapeutics – the submission of our BLA for ONS-5010. In anticipation of potentially providing an on-label, FDA-approved alternative for wet AMD patients in the United States, we are ramping up our pre-commercial launch activities. To support these efforts, we have continued to add to the expertise of our commercial team to build momentum among partners, payors and the retina community. We are focused on positioning ourselves to unlock the full potential of ONS-5010," commented C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics.

ONS-5010 / LYTENAVA (bevacizumab-vikg) Development Updates

Outlook Therapeutics’ wet AMD clinical program for ONS-5010 consists of three completed clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE. With the successful completion of these clinical trials, Outlook Therapeutics submitted its BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in March 2022. If the BLA is approved, it is expected to result in 12 years of marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.

As previously announced, if ONS-5010 receives FDA approval, Outlook Therapeutics plans to submit a supplementary application (sBLA) for approval to provide the product in a pre-filled, silicone oil-liquid free syringe that meets the FDA’s strict specifications for ophthalmic use. To support the anticipated submission of this sBLA, Outlook Therapeutics is conducting its NORSE SEVEN clinical trial to compare the safety of ONS-5010 in vials versus pre-filled syringes. NORSE SEVEN is expected to enroll approximately 120 subjects with visual impairment due to retinal disorders. Patients will be treated for three months and the enrollment of patients in the arm of the study receiving ONS-5010 in vials has already been completed.

Pre-Launch Commercial Planning Underway

According to the National Eye Institute (NEI), use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for at least 50% of all wet AMD injections in the United States each year. Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases.

In anticipation of potential FDA marketing approval in early 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Biopharma Services for finished drug product. The Company also is actively building out its distribution and commercial team structures.

To bring ONS-5010 to market in a way that benefits all stakeholders – patients, clinicians and payors – Outlook Therapeutics has been in collaborative discussions with payors and the retina community. Outlook Therapeutics is also developing registration documents on a parallel path for approvals in Europe and expects to submit them in the fourth quarter of calendar 2022. Outlook Therapeutics continues to explore potential strategic commercialization partners, such as the current partnership with Syntone Biopharma JV in China. Outlook Therapeutics expects ONS-5010, if approved, to be a safe and cost-effective choice for patients, clinicians, and payors worldwide for retinal indications.

In addition to the clinical development program evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO), NORSE FOUR, and two planned registration clinical trials evaluating the drug candidate for the treatment of diabetic macular edema (DME), NORSE FIVE and NORSE SIX.

Upcoming Anticipated Milestones

Receive PDUFA date from FDA;
Continued progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in early 2023; and
Completion in calendar 2022 of the NORSE SEVEN study evaluating Outlook Therapeutics’ vial delivery system versus a pre-filled syringe of ONS-5010.
Financial Highlights for the Fiscal Second Quarter Ended March 31, 2022

For the fiscal second quarter ended March 31, 2022, Outlook Therapeutics reported a net loss attributable to common stockholders of $19.7 million, or $0.09 per basic and diluted share, compared to a net loss attributable to common stockholders of $13.1 million, or $0.09 per basic and diluted share, for the same period last year.

At March 31, 2022, Outlook Therapeutics had cash and cash equivalents of $58.4 million, compared to $70.2 million at December 31, 2021. Outlook Therapeutics’ cash and cash equivalents on hand are expected to provide funding into the first calendar quarter of 2023.

"We believe Outlook Therapeutics is in a strong financial position," stated Lawrence A. Kenyon, Chief Financial Officer of Outlook Therapeutics. "We have successfully accessed capital via our ATM program and plan to continue using this financing option, subject to market conditions. Also, we have initiated discussions with the holders of our unsecured notes to extend the maturity of these notes until 2024 after we begin generating revenue from LYTENAVA, if approved. With these steps, we believe we have charted a path that would allow Outlook Therapeutics to launch LYTENAVA without the need to raise significant additional capital."

About ONS-5010 / LYTENAVA (bevacizumab-vikg)

ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 can replace the need to use unapproved repackaged IV bevacizumab from compounding pharmacies for the treatment of wet AMD.

Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

On May 13, 2022 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, reported financial results for the first quarter of 2022 (Press release, Abeona Therapeutics, MAY 13, 2022, View Source [SID1234614486]). The Company will host a conference call and webcast on Tuesday, May 17, 2022, at 8:30 a.m. ET, to discuss its financial results and business update.

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"During the quarter, we took significant steps to preserve our capital with the goal to fund operations over the next 12 months with existing cash resources," said Vish Seshadri, Chief Executive Officer of Abeona. "First, we began off-loading our MPS assets to reduce cash burn. Second, having completed accrual for the EB-101 pivotal Phase 3 VIITAL study, we are now focusing R&D resources on generating topline results in the third quarter of 2022, while aggressively exploring partnerships for commercialization of EB-101. Furthermore, we have initiated steps toward regaining compliance with Nasdaq listing requirements."

First Quarter and Recent Highlights

Completed patient enrollment in pivotal Phase 3 VIITAL study evaluating EB-101 for recessive dystrophic epidermolysis bullosa (RDEB), and anticipate topline data readout in the third quarter of 2022.
Additional long-term follow up data up to eight years and quality of life data from a completed Phase 1/2 study evaluating EB-101 for RDEB will be presented at the Society of Investigative Dermatology (SID) Annual Meeting, which will be held on May 18-21, 2022 in Portland, OR. The data will be featured in an oral presentation entitled "Long-term efficacy and safety of investigational autologous gene-corrected skin sheets (EB-101) for recessive dystrophic epidermolysis bullosa (RDEB)."
Reported non-human primate data for AAV204, a novel adeno-associated virus (AAV) capsid from Abeona’s AIM capsid library, highlighting its ability to produce more robust transduction in the macula area of the eye following para-retinal administration, which unlike subretinal administration does not create a retinal detachment. The data was featured at the Association for Research and Vision in Ophthalmology (ARVO) 2022 Annual Meeting.
Appointed Joseph Vazzano as Chief Financial Officer, who brings valuable experience while serving as the Chief Financial Officer at Avenue Therapeutics, Inc. where he secured multiple equity financings.
Nasdaq Compliance Plan

Requested a 180-calendar day extension to regain compliance with the Nasdaq Capital Market’s minimum closing bid price requirement of $1.00 per share.
As part of the Company’s strategy to regain compliance, Abeona intends to seek approval of a reverse stock split of the outstanding shares of common stock at a Special Meeting of stockholders at 10:00 am ET on June 14, 2022. Stockholders as of May 3, 2022, the record date, are entitled to attend the online Special Meeting, view the proxy statement and vote at: www.virtualshareholdermeeting.com/ABEO2022SM.
On May 2, 2022, Abeona completed a $25 million private placement offering of convertible redeemable preferred stock. Holders of the preferred stock will vote together with the Company’s common stockholders on a proposal to effect a reverse stock split of the Company’s common stock at the Special Meeting.
First Quarter Financial Results

The unaudited interim condensed consolidated financial statements for the quarter ended March 31, 2022, which were filed on Form 10-Q on May 13, 2022, have been prepared on the going concern basis, which assumes the Company will have sufficient cash to pay its operating expenses, as and when they become payable, for a period of at least 12 months from the date the financial report is issued.

Cash, cash equivalents, restricted cash and short-term investments totaled $37.2 million as of March 31, 2022. Net cash used in operating activities was $13.7 million for the three months ended March 31, 2022.

License and other revenues in the first quarter of 2022 were $0.3 million, compared to nil in the first quarter of 2021. The revenue in the first quarter of 2022 consisted mainly of the recognition of deferred revenue related to grants for the ABO-102 and ABO-101 development programs.

Research and development (R&D) expenses for the three months ended March 31, 2022 were $10.5 million, compared to $8.3 million for the same period of 2021. General and administrative (G&A) expenses were $4.2 million for the three months ended March 31, 2022, compared to $6.3 million for the same period of 2021.

Net loss was $20.8 million for the first quarter of 2022, or $0.14 loss per common share as compared to a net loss of $16.0 million, or $0.17 loss per common share, in the first quarter of 2021. The net loss in the first quarter of 2022 includes $6.2 million in non-cash impairment charges resulting from the disposition of the ABO-102 and ABO-101 development programs as the Company focuses resources on its EB-101 pivotal program and preclinical eye gene therapy programs. The impairment charges have no impact on the Company’s cash position or cash flow from operating activities and do not have an impact on future operations.

Conference Call Details

Abeona Therapeutics will host a conference call and webcast on Tuesday, May 17, 2022, at 8:30 a.m. ET, to discuss its financial results and business update. To access the call, dial 877-545-0320 (U.S. toll-free) or 973-528-0002 (international) and Entry Code: 221025 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at www.abeonatherapeutics.com. The archived webcast replay will be available for 30 days following the call.

On May 13, 2022 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Ocuphire Pharma, MAY 13, 2022, View Source [SID1234614527]).

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"We have kicked off 2022 with a high level of productivity and execution resulting in multiple positive clinical data readouts across our late-stage programs," said Mina Sooch, MBA, founder and CEO of Ocuphire Pharma. "Year to date, we presented at 10 conferences and met with many KOLs, reinforcing the growing awareness and enthusiasm for our programs, particularly among doctors anticipating an eye drop treatment to reverse dilation. We recently reported positive data from the MIRA-3 and MIRA-4 trials, marking completion of the clinical activities to support the planned NDA filing for Nyxol in the Reversal of Mydriasis (RM) indication later this year. In our retinal program, we look forward to reporting top-line Phase 2b data in the second half of the year for APX3330, an novel oral treatment option for the large unmet need of over 7 million diabetic retinopathy patients who are generally asymptomatic with a progressive vision-threatening disease and are not routinely treated with approved anti-VEGF injections. With the approval of the first artificial-intelligence-based screening of diabetic retinal diseases, we expect an increase in the identification of DR patients."

Key Anticipated Future Milestones

Reversal of Mydriasis (RM): Planned New Drug Application (NDA) with the FDA for Nyxol in RM indication in late 2022, with potential launch as first dilation reversal drop in 2H 2023
Presbyopia: Initiate VEGA Phase 3 program in mid-2022 investigating Nyxol alone and Nyxol with 0.4% low-dose pilocarpine (LDP) as adjunctive therapy and, if successful, expect to file an NDA in 2023
Night Vision Disturbances (NVD): Report top-line results from the Nyxol Phase 3 LYNX-1 trial in 2Q 2022
Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME): Report top-line results from the APX3330 Phase 2b ZETA-1 trial in 2H 2022
First Quarter and Recent Business Highlights

Clinical Development

In January, the Company announced new positive data from the VEGA-1 Phase 2 trial for Nyxol as a single agent in presbyopia, showing that one drop of Nyxol had statistically significant improvement in 3 lines of near vision efficacy at 12-hours compared to placebo.
In January, the Company completed enrollment of the LYNX-1 Phase 3 Trial investigating Nyxol for the treatment of night vision disturbances in 145 patients (target of 140).
In February, Ocuphire held a Type-C meeting with the FDA from which it obtained guidance regarding the design of pivotal studies for filing an NDA to seek approvals of Nyxol for the treatment of presbyopia, both as a single agent and with LDP as adjunct therapy eye drops.
In March, the Company announced successful results from the MIRA-3 Phase 3 registration trial of Nyxol for RM, demonstrating significant and rapid reversal of mydriasis. In addition, multiple key secondary endpoints met statistical significance, including early onset of action, durable response over 24 hours, similar efficacy with one or two drops, and efficacy regardless of iris color or mydriatic agent used.
In March, the Company completed enrollment of 103 (target of 90-100) diabetic retinopathy patients in the ZETA-1 Phase 2b trial of first-in-class oral APX3330. Masked safety data from the trial, first announced during the R&D Day event in January 2022 and later presented through May at medical conferences, demonstrated a favorable safety profile, consistent with prior studies.
In April, the Company completed the last clinical trial supporting a planned NDA submission with the announcement of positive results from the MIRA-4 Phase 3 pediatric study evaluating Nyxol for RM. The study met its primary safety endpoint, demonstrating a favorable safety and tolerability profile with no adverse events reported.
Presentations, Publications, and Conferences

In January through May 2022, Ocuphire was represented at conferences by Mina Sooch and several prominent key thought leaders, including David Boyer, MD, David Lally, MD, Jay Pepose, MD, Inder Paul Singh, MD, Douglas Devries, OD, and James Katz, MD, who presented updates on Nyxol in Presbyopia and RM, as well as masked safety data for APX3330 in DR. In total, 16 papers, posters, and panel talks were presented across 10 medical and industry conferences.
Corporate

In January, the Company held an Investor R&D Day webinar that featured six ophthalmic Key Opinion Leaders: Jay Pepose, MD, PhD, James Katz, MD and Mitchell Jackson, MD from refractive surgery, Paul Karpecki, OD from optometry, and David Boyer, MD, and Peter Kaiser, MD, from retina practice areas who discussed the unmet needs in RM, presbyopia and DR addressed by Ocuphire’s two late-stage clinical drug assets, Nyxol and APX3300. A replay of the event can be found on the Company’s corporate website here.

In March, the Company appointed Jay Pepose, MD, PhD, as its Chief Medical Advisor.
First Quarter Ended March 31, 2022 Financial Highlights

As of March 31, 2022, Ocuphire had cash and cash equivalents of approximately $19.2 million. Based on current projections, management believes the current cash on hand will be sufficient to fund operations into the second quarter of 2023. Cash and cash equivalents as of March 31, 2022 was $5.3 million lower than on December 31, 2021.

General and administrative expenses were $1.7 million for each of the three months ended March 31, 2022 and March 31, 2021.

Research and development expenses for the three months ended March 31, 2022 were $4.8 million compared to $3.5 million for the three months ended March 31, 2021. The $1.3 million increase was primarily attributable to an increased activity level associated with clinical trials and manufacturing activities for Nyxol and APX3330 period over period as well as additional preclinical and other development activities during the current period.

The loss from operations for the quarter ended March 31, 2022 was $6.5 million, compared to $5.2 million for the quarter ended March 31, 2021.

Net loss for the quarter ended March 31, 2022 was $6.6 million or ($0.35) per share, compared to $39.0 million or ($3.57) per share for the quarter ended March 31, 2021 which included a non-cash fair value change in warrant liabilities of $33.8 million.

For further details on Ocuphire’s financial results, refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 to be filed with the Securities and Exchange Commission.

On May 13, 2022 EXACT Therapeutics AS ("EXACT-Tx" or "the Company") Euronext Growth: EXTX), a clinical stage biopharmaceutical company with a mission to enhance the therapeutic efficacy of medicines through ultrasound-mediated drug delivery, reported that its new Chief Executive Officer ("CEO") Per Walday will start 6 June 2022 (Press release, Exact Therapeutics, MAY 13, 2022, View Source [SID1234614487]).

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As announced by the Company on 28th March 2022, Per, who worked alongside the Founders and some of the Board Members of EXACT-Tx during his time as Global Head of Project Management at GE Healthcare, is joining EXACT-Tx as CEO. During his time at GE Healthcare, he was responsible for all development programs of new pharmaceutical products which included R&D efforts within the field of ultrasound and microbubbles which paved the way for what would become years later EXACT-Tx’ Acoustic Cluster Therapy (ACT). Per was most recently CEO of PCI Biotech (OSE: PCIB) with a technology involving a drug-device combination developed for use in the field oncology. The experience and wealth of knowledge that he has acquired in those fields will be of enormous help to the success of ACT.

Dr Masha Strømme, Executive Board Chair, commented: "The Board and I look forward to working with Per. His intimate knowledge of ultrasound along with therapeutic expertise and strong leadership will lead the Company through the next phase of its development."

Dr Per Walday, Chief Executive Officer-designate of EXACT-Tx, said: "Remarkable innovation and progress have been made with the ACT platform since I led the development of related ultrasound technology initially aimed for diagnostic use in GE Healthcare. I am very excited to be joining EXACT- Tx in June and aim to further maximise the value of the innovative ACT platform for ultrasound mediated drug enhancement and accelerate our journey towards becoming a leading precision health company."

As a result of Per’s appointment, some of the activities of EXACT-Tx will be relocated to Oslo. Dominic Moreland will be stepping down as Chief Financial Officer ("CFO"). Dominic has a three month notice period and he will work in the transition period with Ole Fegth who will then assume the role of interim CFO. The Board of EXACT-Tx thanks Dominic for his contribution.

On May 13, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal third quarter ended March 31, 2022 and provided a corporate update (Press release, Kintara Therapeutics, MAY 13, 2022, View Source [SID1234614528]).

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CORPORATE HIGHLIGHTS AND RECENT DEVELOPMENTS
Closed a registered direct financing with certain institutional investors pursuant to which the Company received approximately $7.9 million in net proceeds after deducting placement agent fees and other offering expenses payable by the Company (April).

Received notice of the U.S. Patent and Trademark Office’s issuance of United States Patent No. 11,234,955 to VAL-083 covering a method of treating brain tumors including glioblastoma multiforme (GBM), medulloblastoma, and cancer brain tumor stem cells that has O6-methyl guanine methyltransferase (MGMT)-driven drug resistance (February).

Announced that the Global Coalition for Adaptive Research (GCAR) GBM Adaptive Global Innovative Learning Environment (AGILE) registrational Phase 2/3 clinical study (GBM AGILE Study) has screened over 1,000 patients and that enrollment rates for the study are 3 to 4 times greater than traditional GBM studies according to GCAR, with active sites averaging 0.75 to 1 patient per site per month. As a result of the accelerated enrollment rate, the Company expects to announce top-line data from the Kintara arm of the study around the end of calendar year 2023 (January).

Continued to advance development of REM-001 for the treatment of Cutaneous Metastatic Breast Cancer (CMBC), including taking critical steps toward manufacturing sufficient quantity of drug to allow for initiation and completion of the 15-patient confirmatory study. Enrollment of the first patient is expected by the middle of calendar year 2022.
"The enrollment rate in the GBM AGILE Study continues to be robust and is expected to lead to our announcing top-line data for the VAL-083 arm of the study around the end of 2023," commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "Moving our REM-001 CMBC program back into the clinic is also an important step for us to deliver on our mission of serving cancer patients where there is a clear unmet medical need. We remain on track to start enrolling patients in the CMBC study by the middle of calendar year 2022."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2022 THIRD QUARTER ENDED MARCH 31, 2022
At March 31, 2022, Kintara had cash and cash equivalents of approximately $8.8 million. In April 2022, Kintara completed a registered direct offering for net proceeds to the Company of approximately $7.9 million.

For the three months ended March 31, 2022, Kintara reported a net loss of approximately $5.4 million, or $0.11 per share, compared to a net loss of approximately $6.6 million, or $0.23 per share, for the three months ended March 31, 2021. For the nine months ended March 31, 2022, Kintara reported a net loss of approximately $17.2 million, or $0.45 per share, compared to a net loss of approximately $31.6 million, or $1.47 per share, for the nine months ended March 31, 2021. The decreased net loss for the nine months ended March 31, 2022 compared to the nine months ended March 31, 2021 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the Adgero transaction in August 2020.