On February 24, 2022 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the fourth quarter and full year 2021 (Press release, Cytokinetics, FEB 24, 2022, View Source [SID1234609068]). Net loss for the fourth quarter was $30.6 million or $0.36 per share and the net loss for the year 2021 was $215.3 million or $2.80 per share. Net loss for the fourth quarter of 2020 was $43.9 million or $0.62 per share and net loss for the year 2020 was $127.3 million or $1.97 per share. Cash, cash equivalents and investments totaled $623.7 million at December 31, 2021. This cash balance does not include $150 million in proceeds received from transactions executed in late 2021 and early 2022.

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"In the fourth quarter of last year and in early January we were pleased to execute two important transactions, comprising the licensing of omecamtiv mecarbil in China as well as funding for long-term capital supportive of the commercial launch of omecamtiv mecarbil and the further development of aficamten. In the fourth quarter we also continued to build our commercial infrastructure remaining prudent to spending gated to key de-risking events, such as the recent acceptance of the New Drug Application for omecamtiv mecarbil by the U.S. Food and Drug Administration," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "As we look ahead to what may be a pivotal year for our company, we believe that we are in a strong financial position to expand the development program for aficamten and advance our pipeline of early drug candidates while we also deliver on the promise of muscle biology by responsibly transforming from a R&D focused company to one that is also commercial."

Q4 and Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

The U.S. Food and Drug Administration (FDA) accepted and filed our New Drug Application (NDA) for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction (HFrEF). The NDA was assigned standard review with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2022.

Continued building our commercial infrastructure and capabilities and engaged in product launch readiness activities for omecamtiv mecarbil in the U.S. Key launch readiness activities in Q4 focused to market access, distribution strategy, campaign development, pricing, field force size, structure and territory boundaries. Furthermore, the recent NDA filing has triggered additional investments in systems, training programs, supply chain and logistics as we continue to plan for a potential launch.

Continued to expand our therapeutic Medical Scientists team and began development of our Managed Healthcare Medical Science Liaison team. We completed vendor selection for the Medical Contact Center and finalized design of our Investigator Sponsored Study Program.

Announced topline results of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3 clinical trial of omecamtiv mecarbil in patients with HFrEF. METEORIC-HF evaluated the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET). There was no effect on the primary endpoint of change in peak oxygen uptake (pVO2) on CPET from baseline to Week 20 in patients treated with omecamtiv mecarbil compared to placebo. Adverse events, including major cardiac events, were similar between the treatment arms, and the safety profile of omecamtiv mecarbil was consistent with prior clinical trials, including GALACTIC-HF. The results from METEORIC-HF will be presented at the American College of Cardiology 71st Annual Scientific Session & Expo in Washington, D.C., as part of a Late Breaking Clinical Trial session on Sunday, April 3, 2022.

Presented results from additional analyses from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) at the American Heart Association (AHA) Scientific Sessions 2021 showing that treatment with omecamtiv mecarbil was associated with a significant reduction in the risk of stroke.
aficamten (cardiac myosin inhibitor)

Opened enrollment in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM). SEQUOIA-HCM is a Phase 3 randomized, placebo-controlled, double-blind, multi-center clinical trial designed to evaluate aficamten in patients with symptomatic obstructive HCM on background medical therapy for 24 weeks. The primary endpoint is the change in pVO2 measured by CPET from baseline to week 24. SEQUOIA-HCM is expected to enroll 270 patients, randomized on a 1:1 basis to receive aficamten or placebo in addition to standard-of-care treatment. Each patient will receive up to four escalating doses of aficamten or placebo based on echocardiographic guidance alone.

Announced positive topline results from Cohort 3 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), which enrolled patients with symptomatic obstructive HCM and a resting or post-Valsalva left ventricular outflow tract gradient (LVOT-G) of ≥50 mmHg whose background therapy included disopyramide and in the majority a beta-adrenergic blocker. Results showed that substantial reductions in the average resting LVOT-G as well as the post-Valsalva LVOT-G (defined as resting gradient <30 mmHg and post-Valsalva gradient <50 mmHg) were achieved. In addition, the safety and tolerability of aficamten were consistent with prior experience in REDWOOD-HCM with no treatment interruptions and no serious adverse events attributed to treatment reported by the investigators. The results from Cohort 3 of REDWOOD-HCM will be presented at the American College of Cardiology 71st Annual Scientific Session & Expo in Washington, D.C., on Saturday, April 2, 2022.

Received Breakthrough Therapy Designation for aficamten for the treatment of symptomatic obstructive HCM from the (FDA).

The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for aficamten for the treatment of symptomatic obstructive HCM in China.
CK-3828136 (CK-136) (cardiac troponin activator)

Presented preclinical data relating to the discovery and optimization of CK-136 at the 2021 Medicinal Chemistry Gordon Research Conference in West Dover, VT, and presented preclinical data on a closely related analog to CK-136 related to its effect on cardiac contractility and energetics at the American Heart Association (AHA) Scientific Sessions 2021.
Skeletal Muscle Program

reldesemtiv (fast skeletal muscle troponin activator (FSTA))

Continued conduct of COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), the Phase 3 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS).

Presented data from our ALS program at the 32nd International Symposium on ALS/MND, including an analysis of baseline characteristics from the initial 27 patients enrolled in COURAGE-ALS indicating that the majority of patients enrolled to date were categorized as middle or fast progressors. Supplemental analyses presented from FORTITUDE-ALS showed that declining grip strength was strongly correlated with declining fine motor function and declining arm function, and that extremity muscle strength was correlated with physical function and quality of life. Results were also presented from IMPACT ALS, a self-reported online survey of ALS patients and caregivers in Europe exploring perspectives on burden of disease and treatment.
Pre-Clinical Development and Ongoing Research

Continued to advance new muscle directed compounds and conduct IND-enabling studies with the expectation of our potentially moving 1-2 drug candidates into clinical development in the next year.

Continued research activities directed to our other muscle biology research programs.
Corporate

Secured long-term capital from entities affiliated with Royalty Pharma to support the potential commercialization of omecamtiv mecarbil and the further development of aficamten. Royalty Pharma will provide Cytokinetics long-term capital of up to $300 million to support the potential commercialization of omecamtiv mecarbil and the further development of aficamten, and other general corporate purposes. Royalty Pharma also purchased a royalty on aficamten of 4.5% on sales up to $1 billion and 3.5% on sales above $1 billion, subject to certain potential step-downs, in exchange for payments of up to $150 million.

Expanded collaboration with Ji Xing Pharmaceuticals Limited (Ji Xing), a biopharmaceutical company backed by investment funds affiliated with RTW Investments, LP (RTW), by entering into an exclusive license and collaboration agreement to develop and commercialize omecamtiv mecarbil for the proposed treatment of HFrEF in Greater China. The company also entered into Common Stock Purchase Agreements with investment funds affiliated with RTW. Cytokinetics has received committed capital of $70 million, and will receive up to $330 million from Ji Xing in additional milestone payments plus tiered royalties on the net sales of omecamtiv mecarbil in Greater China, subject to certain reductions.
2022 Corporate Milestones

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Launch omecamtiv mecarbil in the U.S. pending FDA approval in Q4 2022.
aficamten (cardiac myosin inhibitor)

Continue enrollment in SEQUOIA-HCM through 2022.

Begin enrolling patients with non-obstructive HCM in Cohort 4 of REDWOOD-HCM in Q1 2022.

Begin second Phase 3 clinical trial of aficamten in obstructive HCM in 2H 2022.

Expect to share data from the open label extension study, REDWOOD-HCM OLE, for patients who complete REDWOOD-HCM, in 2022.
CK-3828136 (CK-136) (cardiac troponin activator)

Reactivate development program for CK-136 in 2H 2022.
Skeletal Muscle Program

reldesemtiv (fast skeletal muscle troponin activator (FSTA))

Expect the Data Monitoring committee to conduct the first interim analysis from COURAGE-ALS in 2H 2022, assessing for futility, 12 weeks after approximately one-third or more of the planned sample size is randomized.
Financials

Revenues for the three and twelve months ended December 31, 2021 were $55.6 million and $70.4 million, respectively, compared to $6.7 million and $55.8 million for the corresponding periods in 2020. The increase in revenues for the year ended December 31, 2021 was primarily due to $54.9 million of license revenue recognized for the transaction with Ji Xing.

Research and development expenses for the three and twelve months ended December 31, 2021 increased to $43.5 million and $159.9 million, respectively, compared to $29.2 million and $97.0 million for the same periods in 2020, respectively, due primarily to increases in spending for clinical development activities for our cardiac muscle inhibitor programs, COURAGE-ALS, facility expenses and for regulatory filing costs. In addition, we incurred transition costs related to the termination of our collaboration with Amgen and our purchase of approximately $14.6 million of material including manufactured quantities of the active pharmaceutical ingredients for omecamtiv mecarbil.

General and administrative expenses for the three and twelve months ended December 31, 2021 increased to $33.8 million and $96.8 million from $13.9 million and $52.8 million in 2020 due primarily to higher outside services spending in anticipation of the potential commercial launch of omecamtiv mecarbil, an increase in personnel related costs including stock-based compensation and facilities expenses for our new headquarters.

2022 Financial Guidance

The company reported financial guidance for 2022. The company anticipates revenue will be in the range of $20 to $25 million, operating expenses will be in the range of $380 to $400 million, and net cash utilization will be approximately $365 to $385 million. Our current cash balance of $724 million, in addition to committed capital expected to be earned upon dosing of the first patient in SEQUOIA-HCM, represents more than two years of forward cash based on our projected operating expenses and net cash utilization.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s fourth quarter results on a conference call today at 4:30 PM Eastern Time. The call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 2895984.

An archived replay of the webcast will be available via Cytokinetics’ website until March 10, 2022. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 2895984 from February 24, 2022 at 7:30 PM Eastern Time until March 10, 2022.

On February 24, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the fourth quarter and the full year ended December 31, 2021 and provided recent corporate highlights (Press release, Y-mAbs Therapeutics, FEB 24, 2022, View Source [SID1234609067]).

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"In recent months, we have achieved significant progress on the omburtamab BLA, which we expect to resubmit to the FDA by the end of the first quarter of 2022," said Dr. Claus Moller, Chief Executive Officer. "We believe we now have a clear regulatory path in place and are one step closer to our goal of delivering omburtamab to children suffering from high-risk neuroblastoma brain tumors. In parallel, we are continuing to advance SADA, our novel platform for targeted radioisotope delivery that can potentially be adapted to various tumor targets. We filed an IND for GD2-SADA, the first SADA construct for potential use in GD2 positive solid tumors and are now accelerating pre-clinical testing with plans to submit at least one IND per year for additional SADA targets. In the meantime, we are actively pursuing additional collaboration and partnership opportunities."

"We are very pleased with our 2021 financial results, especially with our continued execution of the DANYELZA commercial launch, which generated revenues of $32.9 million in its first year," said Thomas Gad, Founder, Chairman and President. "We continue to be focused on our oncology programs, supported by a strong balance sheet. We ended the year with $181.6 million in cash, that is anticipated to support us through multiple potentially value-creating catalysts by the end of 2023. We believe that we are well-positioned to elevate our business and we expect that 2022 will be another productive year for Y-mAbs."

Fourth Quarter 2021 and Recent Corporate Developments

Subsequent to the end of the fourth quarter, on February 11, 2022, Y-mAbs announced the completion of a Pre-BLA Meeting with FDA for omburtamab and confirmed the timeline for resubmission of the omburtamab BLA by the end of the first quarter of 2022.

On December 15, 2021, Y-mAbs announced a pipeline update, including compassionate use data from an investigational infusion protocol for naxitamab. It was observed that the protocol may help managing Grade 3 and Grade 4 adverse events.

On December 14, 2021, Y-mAbs appointed Sue Smith to the role of Senior Vice-President, Chief Commercial Officer, effective January 1, 2022. Ms. Smith brings more than 25 years of extensive commercial experience including several successful product launches within cancer, rare diseases, and endocrinology.

On October 7, 2021, Y-mAbs announced that the U.S. Food and Drug Administration ("FDA") had granted Rare Pediatric Disease Designation ("RPDD") for the Company’s lutetium labeled omburtamab antibody program for the treatment of medulloblastoma.
Financial Results

Revenues

Y-mAbs reported net revenue of $34.9 million for the year ended December 31, 2021, which consisted of product revenues of $32.9 million, generated from sales of DANYELZA, our first FDA approved product, and licensing revenues of $2.0 million related to a licensing agreement in Latin America. The gross margin for product revenues was 93% in 2021. Y-mAbs reported net revenues of $20.8 million for the year ended December 31, 2020, related to its licensing agreements in China and Israel. Y-mAbs did not have product revenues for the year ended December 31, 2020, as DANYELZA was not approved by the FDA until late November 2020.

For the fourth quarter of 2021, Y-mAbs incurred net revenues of $9.6 million, which consisted of product revenues from the sales of DANYELZA. Sales were up 7.1% from the third quarter 2021, and we have now delivered DANYELZA to 28 centers across the nation, an increase of four centers since the third quarter 2021. Treatment centers outside MSK accounted for approximately 40% of the product revenues during the fourth quarter of 2021. Y-mAbs incurred net revenues of $20.8 million for the quarter ending December 31, 2020, related to its licensing agreements in China and Israel.

Operating Expenses

Research and Development

Y-mAbs is anticipating a BLA resubmission for omburtamab by the end of the first quarter 2022 and at the same time, the Company is advancing its antibody constructs through the clinic; predominantly DANYELZA, omburtamab, and the SADA constructs. Research and development expenses were $93.2 million for the twelve months ended December 31, 2021, compared to $93.7 million for the twelve months ended December 31, 2020. The $0.5 million decrease in research and development expenses primarily reflects the following main items:

$4.8 million decrease in regulatory affairs expenses; and
$13.3 million decrease in milestones and license acquisition costs.
The decreases mentioned above were partially offset by the following increases:

$6.2 million increase in outsourced manufacturing expenses;
$4.1 million increase in personnel costs associated with research and development activities; and
$3.9 million increase in clinical trial expenses.
Selling, General, and Administration

Selling, general, and administrative expenses were $54.6 million for the twelve months ended December 31, 2021, compared to $44.8 million for the twelve months ended December 31, 2020, corresponding to an increase of $9.8 million. The increase in selling, general, and administrative expenses was primarily due to a $8.9 million increase in personnel costs, partly associated with the expansion of our commercial team that is poised to drive further adoption of DANYELZA in 2022.

Net Result

Y-mAbs reported a net loss of $55.3 million, or ($1.28) per basic and diluted share, for the year ended December 31, 2021, compared to a net loss of $119.3 million, or ($2.97) per basic and diluted share, reported for the year ended December 31, 2020. The decrease in net loss was primarily caused by the sale in January 2021 of the priority review voucher received upon the approval of DANYELZA and the DANYELZA revenues generated in 2021, partially offset by increases in operating expenses related to the commercialization of DANYELZA in the United States.

For the quarter ended December 31, 2021, Y-mAbs incurred a net loss of $36.9 million, or ($0.85) per basic and diluted share, which compares to a net loss of $19.9 million, or ($0.48) per basic and diluted share, incurred for the quarter ended December 31, 2020. The increase in net loss was primarily caused by the DANYELZA revenues in 2021 not fully offsetting the licensing income in the fourth quarter of 2020.

Cash and Cash Equivalents

The Company had approximately $181.6 million in cash and cash equivalents as of December 31, 2021.

Webcast and Conference Call

The Company will host a conference call on Friday, February 25, 2022, at 9 a.m. Eastern Time. To participate in the call, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and reference the conference ID 13726652.

A webcast will be available at: View Source;tp_key=59e1f9cc51

On February 24, 2022 EVERSANA reported that it will be attending Reuters Events: Pharma USA 2022 on March 16th & 17th in Philadelphia (Press release, EVERSANA, FEB 24, 2022, View Source [SID1234609061]). Krista Pinto, President, Deployment Solutions, will participate with industry leaders in a panel discussion covering the importance of salesforce instances keeping pace with rapidly evolving HCP preferences March 17th at 12:20 PM EST . Key topics include:

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With a shift in HCP preferences, expectations and a hybrid future, learn how to maximize your salesforce outputs by shifting the way your organization sets KPI’s as well as the metrics used to read them
New methods to provide value to your HCPs in virtual calls
Learn how to match HCP preferences with sales rep interactions to leave long-lasting impressions that lead to conversions
How can we you empower the digital rep experience from a service orientation perspective?
Confirmed speakers:

Krista Pinto, President, Deployment Solutions, EVERSANA
Dion Warren, VP, Head of U.S. Oncology Business Unit, Takeda
Frank Armenante, Director, Commercial Execution, Novo Nordisk
Tatiana Yglesias, Head of Migraine Marketing, Neuroscience, Novartis
Nithya Srinivasan, Director of Marketing, Rheumatology, Janssen
Pharma USA unites North America’s visionary pharma changemakers, leading solution providers, patient experts and industry heavyweights — from commercial, marketing, medical affairs, patient engagement, market access and RWE — who’ll unlock unrestrained innovation and drastically improved health outcomes.

On February 24, 2022, Amgen Inc. (the Company) reported that entered into accelerated stock buyback agreements, pursuant to the form of ASR Agreement filed herewith (hereinafter referred to as the ASR Agreements), with each of Bank of America, N.A., Morgan Stanley & Co. LLC, and Goldman Sachs & Co. LLC (each, a Financial Institution, and together, the Financial Institutions) to repurchase an aggregate of up to $6 billion of the Company’s common stock, as previously announced on February 8, 2022 (Filing, 8-K, Amgen, FEB 24, 2022, View Source [SID1234609057]). The Company is funding the share repurchases under the ASR Agreements with existing cash resources.

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Under the terms of the ASR Agreements, the Company will make payments in an aggregate amount of $6 billion to the Financial Institutions on February 25, 2022, and expects to receive on the same day initial deliveries of approximately 23,258,997 shares of the Company’s common stock in the aggregate from the Financial Institutions. The final number of shares to be repurchased by the Company will be based on the volume-weighted average stock price of the Company’s common stock during the term of the ASR Agreements, less a discount and subject to adjustments pursuant to the terms and conditions of the ASR Agreements. At settlement, under certain circumstances, one or more of the Financial Institutions may be required to deliver additional shares of common stock to the Company, or under certain circumstances, the Company may be required to deliver shares of common stock or to make a cash payment, at its election, to a Financial Institution. The final settlement under the ASR Agreements is scheduled to occur in the third quarter of 2022, subject to earlier termination under certain limited circumstances, as set forth in the ASR Agreements.

Each of the ASR Agreements contains customary terms for these types of transactions, including, but not limited to, the mechanisms to determine the number of shares or the amount of cash that will be delivered at settlement, the required timing of delivery of the shares, the specific circumstances under which adjustments may be made to the transactions, the specific circumstances under which the transactions may be terminated prior to their scheduled maturities and various acknowledgements, representations and warranties made by the Company.

From time to time, one or more of the Financial Institutions and/or their affiliates have directly and indirectly engaged, and may engage in the future, in investment and/or commercial banking transactions with the Company for which such Financial Institution has received, or may receive, customary compensation, fees and expense reimbursement.

The foregoing description of the ASR Agreements does not purport to be complete and is qualified in its entirety by reference to the form of the ASR Agreement, a copy of which is attached hereto as Exhibit 10.1, and is incorporated herein by reference.

On February 24, 2022 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company"), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival by avoiding and overcoming cancer treatment resistance, reported financial results for the quarter ended December 31, 2021 (the "third quarter") (Press release, Portage Biotech, FEB 24, 2022, View Source [SID1234609046]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"During the third quarter and in recent weeks we’ve taken steps to accelerate our lead programs for PORT-2 and PORT-3, investigating options to expand our clinical sites beyond our current footprint and finding the means of accelerating patient enrollment," said Dr. Ian Walters, chief executive officer of Portage. "With our enhanced management team, efficient organization, and financial resources obtained in 2021, we are well positioned to execute our unique drug development strategy to deliver on important clinical milestones over the next two years."

Business Update

Enhanced the management team with the appointments of Brian Wiley as Chief Business Officer, Joseph Ciavarella as Chief Accounting Officer; expanded the Board of Directors with the addition of Jim Mellon, Linda Kozick, and Mark Simon.
Enrollment continues in the Company’s IMP-MEL randomized Phase 1/2 study of PORT-2 and its PRECIOUS Phase 1 study of PORT-3 in patients with NY-ESO-1 expressing tumors.
The Company plans to issue a Research & Development update in March 2022 which will include preliminary safety data on its PORT-2 and PORT-3 programs as well as other details from its clinical development plan.
Presented at high-profile investor conferences:
Management participated in January 2022 investor conferences including the LifeSci Advisors Corporate Access Event, H.C. Wainwright BioConnect Conference, and the B. Riley Securities’ Oncology Investor Conference.
Hosted Key Opinion Webinar How iNKT Agonists Could Improve Immuno-Oncology Treatment with leading researchers from La Jolla Institute of Immunology and Imperial College London. Replay available here.
Third Quarter FY 2022 Financial Results

The Company generated a net loss and comprehensive loss of approximately $4.2 million in the three months ended December 31, 2021 ("Fiscal 2022 Quarter"), compared to a net loss and comprehensive loss of approximately $1.3 million in the three months ended December 31, 2020 ("Fiscal 2021 Quarter"), an increase in loss of $2.9 million year over year. Operating expenses, which include research and development and general and administrative expenses, were approximately $4.2 million in the Fiscal 2022 Quarter, compared to $0.9 million in the Fiscal 2021 Quarter, an increase of $3.3 million, which is discussed more fully below.

The Company’s other items of income and expense were substantially non-cash in nature and were approximately $0.1 million net income in the Fiscal 2022 Quarter, compared to approximately $0.5 million net loss in the Fiscal 2021 Quarter, a change in other items of income and expense of approximately $0.6 million, year over year. The primary reasons for the year over year difference in other items of income and expense was the change of $0.8 million in the fair value of the warrants issued with respect to the SalvaRx note settlement, which was partially offset by the year over year increase in the loss from an associate accounted for under the equity method of $0.1 million and the income on equity issued at a discount of $0.1 million in the Fiscal 2021 Quarter, representing the difference between the market price and the contractual exercise price, relating to the settlement of the SalvaRx notes and warrants.

Research & development ("R&D") costs increased by approximately $1.5 million, from approximately $0.4 million during the Fiscal 2021 Quarter, to approximately $1.9 million during the Fiscal 2022 Quarter. The increase was primarily attributable to non-cash share-based compensation expense associated with grants made under the 2021 Equity Incentive Plan of $1.0 million and salaries and bonuses of $0.7 million to directors and senior management. Additionally, the Fiscal 2021 Quarter was impacted by a general slow down in expenditures resulting from the pandemic.

General and administrative ("G&A") expenses increased by approximately $1.8 million, from approximately $0.4 million during the Fiscal 2021 Quarter, to approximately $2.2 million during the Fiscal 2022 Quarter. The principal reason for the increase in the Fiscal 2022 Quarter was the $1.1 million of non-cash share-based compensation expense associated with the Company’s 2021 Equity Incentive Plan, of which $0.7 million is associated with Directors’ compensation, and $0.4 million is associated with management compensation. No share-based compensation expense under the 2021 Equity Incentive Plan was incurred during the Fiscal 2021 Quarter. Additionally, the Company incurred an increase of $0.4 million in professional fees relating to initiatives associated with a corporate restructuring and public relations / business development. Finally, D&O insurance premiums increased $0.4 million in the current year period due to market rate increases in the cost of coverage.

Additionally, the Company reflected a net income tax expense of approximately $0.1 million in the Fiscal 2022 Quarter, compared to a net income tax benefit of approximately $0.1 million in the Fiscal 2021 Quarter. The Fiscal 2022 Quarter reflects the change in the foreign currency exchange rate on deferred tax liability settleable in British pounds sterling and the Fiscal 2021 Quarter reflected recoverable research and development tax credits generated in the U.K.

As of December 31, 2021, the Company had cash and cash equivalents of approximately $25.6 million and total current liabilities of approximately $0.6 million (inclusive of approximately $0.2 million warrant liability settleable on a non-cash basis). For the nine months ended December 31, 2021, the Company is reporting a net loss of approximately $10.3 million and cash used in operating activities of approximately $4.5 million. As of January 31, 2022, the Company had approximately $25.1 million of cash on hand to enable achieving important clinical milestones over the next two years.