On March 31, 2022 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease, reported financial results for the year ended December 31, 2021 (Press release, Adamis Pharmaceuticals, MAR 31, 2022, View Source [SID1234611297]).

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"We managed to achieve all of our internal objectives for 2021," stated Dennis J. Carlo, Ph.D., President and Chief Executive Officer of Adamis Pharmaceuticals. "Included among them, we began enrolling patients in a Phase 2/3 clinical trial evaluating Tempol as a treatment of COVID-19, resubmitted our NDA for ZIMHI and subsequently received FDA approval."

Product and Pipeline Updates and Other Corporate Developments

ZIMHI

•In October 2021, the U.S. FDA approved ZIMHI TM (naloxone HCL Injection, USP) 5 mg/0.5 mL for the treatment of opioid overdose.

•Drug overdoses are now the leading cause of death for Americans under age 50. Powerful synthetic opioids, like fentanyl and its analogues, are responsible for approximately 85% of all opioid overdose related deaths in the U.S.

•According to the Centers for Disease Control and Prevention (CDC), drug overdoses resulted in over 100,000 deaths in the U.S. during the 12-month period ending April 2021, which was a 29% increase over the prior year.

•Earlier today, Adamis and our U.S. commercial partner, US WorldMeds, jointly announced the nationwide commercial launch of ZIMHI.

SYMJEPI

•Despite the challenges posed by the pandemic and related lockdowns, Symphony Health data indicates SYMJEPI retail scripts increased approximately 115% and total unit sales increased approximately 124% in 2021, compared to the same period of 2020.

•On March 21, 2022, Adamis announced a voluntary recall of certain lots of SYMJEPI. The recall is being conducted with the knowledge of the FDA.

•Manufacturing of SYMJEPI is on hold pending the results of an investigation currently underway to determine the root cause. The Company anticipates a resolution and resumption of manufacturing after the investigation is completed and any issues are satisfactorily addressed.

TEMPOL

•In September 2021, the first patient was enrolled into the Company’s ongoing Phase 2/3 clinical trial of Tempol as a treatment for COVID-19. As of today, 140 patients have been enrolled in the clinical trial.

•On March 11, 2022, the Data Safety Monitoring Board (DSMB) overseeing the Tempol trial met to evaluate the clinical and safety data from the first planned interim analysis. Following their evaluation, the DSMB recommended that the study continue without modification.

•In addition to the work in COVID, the Company is exploring additional indications for the use of Tempol including, but not limited to the treatment of asthma, long COVID and methamphetamine use disorder.

US COMPOUNDING

•During July 2021, the Company sold assets relating to its US Compounding human compounding pharmacy business. Adamis expects to receive monthly payments over a 12-month period in an amount equal to one to two times the amount collected for sales of products to certain identified customers included in the sale.

•The Company is continuing a process of selling or otherwise disposing of the remaining assets of US Compounding.

Financial Results

Despite the significant increase in retail scripts for, and unit sales of, SYMJEPI in 2021 compared to 2020, reported net revenues from continuing operations for the year ending December 31, 2021 were $2.2 million compared to $2.8 million in 2020, reflecting the effect and impact of a $2.0 million reserve reflected in the Company’s financial statements related to the SYMJEPI recall.

As a result of the SYMJEPI voluntary recall in March, we have reserved approximately $2.0 million as a reduction of revenue for the year ended 2021. The company may recover some or all of the cost of the recall from certain third parties under the terms our manufacturing agreements, but the amount of the cost and recovery cannot be determined at this time.

Selling, general and administrative expenses for the years ending December 31, 2021 and 2020 were $16.1 million and $20.1 million, respectively. The decrease was primarily attributable to the reduction in expenses related to legal, compensation related to employee terminations, including forfeitures of stock compensation, and depreciation and amortization.

Research and development expenses were approximately $11.3 million and $8.0 million for the years ending December 31, 2021 and 2020, respectively. The increase in R&D expense was primarily due to development costs related to ZIMHI and Tempol.

Net loss from discontinued operations for the twelve months ended December 31, 2021, and 2020 was $11.2 million and $13.5 million, respectively. The decrease in loss was primarily due to the offset by the gain from the sale of assets.

Cash and equivalents as of December 31, 2021, totaled approximately $23.2 million. In 2022, the Company expects to receive additional proceeds resulting from amounts payable to Adamis pursuant to the sale of certain of the USC assets to Fagron and from the disposition of the remaining USC assets which includes the land, the building, the machinery and the equipment.

Conference Call

Adamis will host a conference call and live webcast today, March 31, 2022, at 2 p.m. PT (5 p.m. ET) to discuss its financial and operating results for the year ended December 31, 2021, as well as provide an update on business developments and activities.

A live audio webcast of the conference call will also be available via this link – View Source;tp_key=857fdc0361. If you are unable to participate in the live call, a replay will be available shortly after the live event. To listen to the replay please visit the events page of the Adamis investor relations section of the company website at View Source

On March 31 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported financial results for the full year ended December 31, 2021 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAR 31, 2022, View Source [SID1234611296]).

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"2021 was an important year for Inhibikase as we advanced our lead program IkT-148009 for Parkinson’s disease into the clinic, continued to develop our early-stage pipeline programs and strengthened our balance sheet to support our development efforts well into 2023," commented Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "Just recently, we presented results from our Phase 1 and 1b study of IkT-148009 in patients with mild to moderately advanced Parkinson’s disease at the annual AD/PD meeting. We believe these data continue to validate the safety and therapeutic potential of IkT-148009. As we look ahead, we hope to share more about our development strategy for this program including the upcoming Phase 2a study at our upcoming virtual KOL investor event on April 20th. Looking to our earlier programs, we are also continuing to advance IkT-148009 in animal models of Multiple Systems Atrophy (MSA), as well as plan to submit our IND application for IkT-001Pro, both in the second quarter. We view 2022 as a year of execution across our pipeline and look forward to providing updates throughout the year as we seek to improve the lives of patients suffering from a devastating neurodegenerative disease."

Recent Developments and Upcoming Milestones:

Phase 1b clinical trial of IkT-148009: The Phase 1b study is a 3:1 randomized, placebo-controlled dose escalation trial evaluating the safety, tolerability, and pharmacokinetics of seven-day dosing of IkT-148009 at three escalating dose levels. The study is also assessing motor and non-motor function, gut motility, and measures of alpha-synuclein aggregate clearance as exploratory endpoints. In March, the Company presented data from the first cohort at the Alzheimer’s & Parkinson’s Diseases Conference (AD/PD). Data demonstrated that the safety and tolerability profile in patients closely matched that of older healthy volunteers. Pharmacokinetics of IkT-148009 in volunteers and subjects was also similar, indicating that IkT-148009 pharmacology is consistent across the patient groups and penetrates the Central Nervous System. The Company expects to complete dosing of the Phase 1b study in the second quarter of 2022 and present full data at a medical meeting later this year.

Phase 1 dose escalation of IkT-148009 in older and elderly healthy volunteers: Inhibikase continues to evaluate IkT-148009 in older and elderly healthy volunteers as part of the Phase 1 study. The Company has completed dose escalation studies through 325 mg. To date, no clinically significant adverse events have been observed at any dose.

Phase 2a clinical study for IkT-148009 in patients with Parkinson’s Disease: Inhibikase expects to dose the first patient in a Phase 2a study of IkT-148009 in untreated Parkinson’s Disease in the second quarter of 2022, subject to agreements with the FDA. The 3:1 randomized, double-blind, twelve-week dosing trial will evaluate the safety and tolerability of three doses of IkT-148009 in up to 120 patients diagnosed with Parkinson’s disease who have not yet progressed to the need for symptomatic therapy. The trial will also measure motor and non-motor function inside and outside of the brain as secondary endpoints and evaluate whether treatment with IkT-148009 leads to a reduction or clearance of pathogenic alpha-synuclein aggregates as exploratory endpoints.

Investigational New Drug application (IND) for IkT-001Pro for stable-phase Chronic Myelogenous Leukemia (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). The Company is completing clinical batch manufacturing of pill formulated IkT-001Pro and conducting required stability studies and expects to submit the IND for IkT-001Pro in the second quarter of 2022. The Company expects to commence bioequivalence studies in accordance with the 505(b)(2) regulatory pathway agreements with the FDA.

Preclinical studies evaluating IkT-148009 in animal models of Multiple System Atrophy (MSA) in preparation for Phase 2 clinical studies: Inhibikase expects to report preclinical data studying IkT-148009 in at least one of two animal models of MSA prior to dosing of MSA patients. The studies are evaluating whether inhibition of the Abelson Tyrosine Kinase, or c-Abl, could have a therapeutic benefit in MSA. The potential role of c-Abl in the disease process was highlighted in the Company’s recent publication published in the peer reviewed journal Neurobiology of Disease[1]. Depending on the preclinical results in animal models of MSA and subject to agreement with the FDA and equivalent regulatory bodies in the European Union, Inhibikase may advance IkT-148009 into a Phase 2a clinical study in the third quarter of 2022.
Upcoming Events:

Virtual KOL Investor Event
Date: April 20, 2022
Time: 10:00am ET
Registration Link: View Source

Inhibikase’s executive leadership team and featured Key Opinion Leaders will host a virtual presentation highlighting the Company’s recent clinical progress including a review of the recently reported Phase 1 data for its lead asset, IkT-148009 as well as an overview of the upcoming Phase 2 program. Additional presentations will highlight the current unmet need and competitive landscape in Parkinson’s disease.

Full Year 2021 Financial Results

Grant Revenue: Grant revenue was $3.1 million for the year ended December 31, 2021 compared to $0.7 million in the prior year. The increase was driven by increased grant research activity during 2021 compared to 2020. During 2020, the Company’s focus was shifted toward advancing its Phase I clinical trials which did not result in grant revenue. The Company utilized its working capital and personnel resources in 2021 to carry on its Phase I clinical trial in addition to its grant research activity.

R&D Expenses: Research and development expenses were $11.4 million for the year ended December 31, 2021 compared to $0.9 million in the year ended December 31, 2020. The increase was primarily due to a full year of increased activity in our Parkinson’s disease Phase I clinical trial.

SG&A Expenses: Selling, general and administrative expenses for the year ended December 31, 2021 were $6.5 million compared to $2.6 million for the year ended December 31, 2020. The increase was primarily due to increased liability insurance, legal and accounting fees, board costs, investor relations and consulting fees associated with operating for the first full year as a public company.

Net Loss: Net loss for the year ended December 31, 2021 was $14.8 million, or $0.81 per share, compared to a net loss of $2.8 million, or $0.35 per share in the year ended December 31, 2020.

Cash Position: Cash and cash equivalents were $40.8 million as of December 31, 2021. The Company expects that existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the third quarter of 2023.

On March 31, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Dr. Anna Berkenblit, Chief Medical Officer, will participate in the Reshaping Ovarian Cancer panel discussion at the upcoming Canaccord Genuity Horizons in Oncology Virtual Conference (Press release, ImmunoGen, MAR 31, 2022, View Source [SID1234611295]). The panel is scheduled for April 14, 2022 from 8:00 – 8:50am ET .

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A webcast of the panel will be accessible through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.

On March 31, 2022 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win technology platform, reported financial results for the year ended December 31, 2021 (Press release, IO Biotech, MAR 31, 2022, View Source [SID1234611294]).

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"The past year has been a transformative period for IO Biotech, during which we made substantial progress developing our promising pipeline," said Mai-Britt Zocca, Ph.D., President and Chief Executive Officer of IO Biotech. "We believe our platform and product candidates may represent a paradigm shift in the management of cancer, and that they have the potential to become cornerstones of treatment regimens for multiple solid tumors. The publication of the compelling high response rate data from the Phase 1/2 MM1636 melanoma trial in Nature Medicine supports the potential of IO102-IO103 in this patient population. Clinical updates from this study will be presented at the AACR (Free AACR Whitepaper) meeting next month. Although we are experiencing longer than expected lead times in clinical trial site activation and patient enrollment, we look forward to progressing this lead asset in the ongoing global Phase 3 trial. We will be providing an update during the middle of this year on the anticipated timing of receiving interim data from this trial. With a solid balance sheet as a result of our successful capital raises and initial public offering in 2021, we were able to debut as a public company with a substantial cash runway to carry us through multiple data readouts into mid-2024."

Highlights from 2021 & Recent Weeks

Announced the publication of clinical data in Nature Medicine from the Phase 1/2 MM1636 study of IO102-IO103 in combination with nivolumab in metastatic melanoma; updated data cut as of December 1, 2021 including multiple sub-group analyses to be presented for the first time at AACR (Free AACR Whitepaper) 2022
Initiated clinical collaboration with Merck to evaluate IO102-IO103 with KEYTRUDA (pembrolizumab) as first-line treatment of advanced melanoma patients in a Phase 3 trial
Initiated clinical collaboration with Merck to evaluate IO102-IO103 in combination with KEYTRUDA (pembrolizumab) as first-line treatment of metastatic solid tumors in a Phase 2 multi-cohort basket trial
Began patient recruitment for global Phase 3 combination trial with our lead asset IO102-IO103 and KEYTRUDA (pembrolizumab) as first-line treatment in advanced melanoma
Strengthened leadership team and Board of Directors, and expanded the Company’s global footprint
Raised $253 million in new capital investment in 2021; debuted as a public company on the Nasdaq exchange November 2021
2021 Financial Results

Net loss was $67.9 million for the year ended December 31, 2021 compared to $12.0 million for the prior year period. The increase in net loss was primarily related to an increase in research and development and general and administrative expenses, as well as increase in other expense primarily related to an increase in the fair value adjustments on preferred stock tranche of $26.5 million.
Research and development expenses were $30.2 million for the year ended December 31, 2021, compared to $8.5 million for the prior year period. The increase of $21.7 million was primarily related to an increase in costs for clinical trial-related activities for our IO102-IO103 product candidate, including the completion of our Phase 1/2 clinical studies, of $9.8 million, which includes $2.9 million in one-time costs triggered by our IPO, an increase in chemistry, manufacturing and control, or CMC, activities of $5.0 million as well as an increase in personnel costs of $5.4 million primarily related to an increase in headcount and related recruiting cost.
General and administrative expenses were $11.1 million for the year ended December 31, 2021, compared to $1.7 million for the prior year period. The increase of $9.4 million was primarily related to an increase in professional services of $3.1 million related primarily to corporate legal fees and audit and tax fees and other consulting costs in support of our growth as well as an increase in personnel costs of $2.4 million primarily related to an increase in headcount and related recruiting costs and an increase in consultants, insurance and other costs of $3.8 million.
Cash and cash equivalents of $211.5 million at December 31, 2021; cash runway sufficient to support operations through multiple data readouts into mid-2024.
About the MM1636 Clinical Trial

The MM1636 trial (ClinicalTrials.gov: NCT03047928), an investigator-initiated trial at the Copenhagen University Hospital, Herlev, enrolled 30 patients with metastatic melanoma. In this Phase 1/2 clinical trial, patients received the multi-antigen immunotherapeutic, IO102-IO103, in combination with the anti-programmed death 1 (PD-1) antibody nivolumab as first line treatment. Patients were treated with nivolumab every second week as long as there was a clinical benefit or no adverse events prohibiting further treatment. IO102-IO103 was given from the start of administration of nivolumab and every second week for the first six weeks and thereafter, every fourth week for 41 weeks. The trial objectives were to assess safety, immune response in blood and biopsies as well as efficacy.

About the IOB-013 / KN-D18 Clinical Trial

IOB-013 / KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment will be 300 patients from centers spread across Europe, Australia, and the United States. Biomarker analyses will also be conducted. IO Biotech will sponsor the Phase 3 trial and Merck will supply pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

On March 31, 2022 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," or "our") (Nasdaq: IDRA) reported its financial and operational results for the fourth quarter and year ended December 31, 2021 (Press release, Idera Pharmaceuticals, MAR 31, 2022, View Source [SID1234611293]).

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"We are actively identifying and evaluating new development or commercial-stage assets for Idera’s portfolio while we continue to preserve cash," stated Vincent Milano, Idera’s Chief Executive Officer. "In addition, we have asked JMP Securities LLC, our current partner and advisor on business development activities, to expand their current scope of work beyond acquisition or in-licensing opportunities to include additional strategic alternatives for the Company."

Fourth Quarter Financial Results

Our cash position as of December 31, 2021 was $32.5 million. Based on our current operating plan, we anticipate that our current cash and cash equivalents will fund our operations through the one-year period subsequent to the March 31, 2022 filing date of the Annual Report Form 10-K.

Research and development expenses for the three months ended December 31, 2021 totaled $2.1 million, compared to $5.1 million for the same period in 2020. General and administrative expense for the three months ended December 31, 2021 totaled $2.0 million, compared to $2.9 million for the same period in 2020.

Additionally, during the three months ended December 31, 2020, we recorded $3.2 million and $65.4 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to the change in fair value of securities issued in connection with our December 2019 private placement transaction. No such non-cash losses were recognized in the three months ended December 31, 2021, as the warrants and future tranche rights were terminated in the first quarter of 2021.

As a result of the factors above, net loss applicable to common stockholders for the three months ended December 31, 2021 was $4.1 million or $0.08 per basic and diluted share compared to net loss applicable to common stockholders of $76.7 million or $2.11 per basic and diluted share for the same period in 2020. Excluding the non-cash loss of approximately $68.6 million for the three months ended December 31, 2020 related to the change in fair value of securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $8.1 million.

Full Year Results

Research and development expenses for the year ended December 31, 2021 totaled $16.4 million compared to $24.8 million for the same period in 2020. General and administrative expenses for the year ended December 31, 2021 totaled $10.0 million compared to $11.9 million for the same period in 2020. Restructuring costs for the year ended December 30, 2021 totaled approximately $1.3 million and relate to a reduction in force initiated in April 2021 to better align our workforce to our ongoing operational and business development activities. No such restructuring costs were incurred during 2020.

Additionally, during the year ended December 31, 2021 we recorded $7.0 million and $118.8 million non-cash warrant revaluation gain and non-cash future tranche right revaluation gain, respectively, related to the termination of securities issued in connection with our December 2019 private placement transaction in the first quarter of 2021. The losses of non-cash warrant revaluation and non-cash future tranche right revaluation were $3.7 million and $72.4 million, respectively, for the same period in 2020.

As a result of the factors above, net income applicable to common stockholders for the year ended December 31, 2021 was $96.9 million or $1.97 per basic share compared to net loss applicable to common stockholders of $112.7 million or $3.33 per basic share for 2020. On a diluted basis, net loss applicable to common stockholders for the year ended December 31, 2021 was $28.8 million or $0.58 per diluted share compared to net loss applicable to common stockholders of $112.7 million or $3.33 per diluted share for 2020.

Excluding the non-cash gain of approximately $125.8 million related to the termination of securities issued in connection with the December 2019 private placement transaction in the first quarter of 2021, net loss applicable to common stockholders for the year ended December 31, 2021 was $28.8 million. Excluding the non-cash loss of approximately $76.1 million related to the change in fair value of securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders for the year ended December 31, 2020 was $36.6 million.