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 [SID1234609033]).

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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.

On February 24, 2022 Aucentra Therapeutics reported that it has received regulatory approval to progress to a Phase 1a/b clinical trial of Auceliciclib (AU3-14) in combination with Temozolomide for recurrent/refractory GBM patients (Press release, Aucentra, FEB 24, 2022, View Source [SID1234609032]). Aucentra’s first-in-human clinical trial commenced in June 2021 and is currently enrolling participants at cohort 4 across three sites in Australia with the primary objective of evaluating the safety and tolerability of Auceliciclib as a monotherapy in patients with advanced solid tumours.

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To date, the ongoing Phase 1a monotherapy arm has shown Auceliciclib to be well tolerated and safe at dose levels up to cohort 4 when administered orally once daily for 21 days per cycle. Based on the encouraging results, Aucentra obtained regulatory approval on 15th February 2022 to concurrently conduct a GBM patient arm, which involves dose escalation as a combination therapy of Auceliciclib together with standard of care Temozolomide therapy for relapsed and refractory GBM patients. This combination therapy escalation arm will then expand at the recommended Phase 2 dose level and further evaluate the potential efficacy of Auceliciclib in improving patient outcomes for this difficult to treat disease. The approval to proceed to the combination arm is based on the encouraging preliminary safety data from the monotherapy Phase 1a arm, and on the supporting preclinical data, which has revealed synergistic efficacy when used in combination with Temozolomide. This clinical trial has been designed specifically to provide an alternative treatment option for GBM patients where there is a large unmet need due to limited treatment options for this aggressive disease.

Aucentra would like to express sincere gratitude to the Principal Investigators at our clinical trial sites in Australia, Dr Ganessan Kichenadasse, Dr Hui Gan and Dr Adam Cooper who have supported us in achieving this significant milestone. Aucentra also recognises the contribution of the key team members Professor Shudong Wang, Dr Paul Wabnitz, Dr Jasmine Karanjia and Ms Charmaine Symons who have been instrumental in the conceptualization, design and successful execution of this trial. Aucentra would like to acknowledge Seed-Start funding from the Government of South Australia, Department for Innovation and Skills that supports the GBM component of this trial.

On February 24, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technology, reported the presentation of preliminary safety data (Press release, PDS Biotechnology, FEB 24, 2022, View Source [SID1234609031]). The data are based on a total of 18 checkpoint inhibitor (CPI) naïve patients from the Company’s ongoing VERSATILE-002 Phase 2 study. The study is being conducted in collaboration with Merck (known as MSD outside the US and Canada) (NCT04260126). The data from the study will be presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium.

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The Phase 2 trial studies PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer. The trial is designed to treat both CPI naïve and refractory patients and will assess the primary efficacy endpoint, as well as partial response per RECIST 1.1. The Company previously announced that it had achieved its preliminary efficacy milestone in the CPI naive arm earlier this month.

Patients in the trial are treated with KEYTRUDA 200 mg intravenously every three weeks plus PDS0101 delivered subcutaneously with KEYTRUDA on cycles of 1-4 and again at cycle 12. An initial safety cohort was assessed during cycle 1 and 21 days following for dose-limiting toxicity, and thereafter for safety and tolerability of the combination.

Highlights from the PDS Biotech’s presentation at the 2022 Multidisciplinary Head and Neck Cancers Symposium regarding the preliminary results of the Phase 2 trial studying PDS0101 in combination with KEYTRUDA for the treatment of recurrent or metastatic HPV16-positive head and neck cancer include the absence of dose-limiting toxicities, drug discontinuation related to toxicity, or immune-related adverse events. Subjects received a median of 4 doses of PDS0101 (range 1-5) and a median of 6 doses of KEYTRUDA (range 1-13). In addition, no treatment-related grade 3 or higher toxicities were reported.

Preliminary safety data has shown that PDS0101 in combination with KEYTRUDA for the treatment of recurrent or metastatic HPV16-positive head and neck cancer is likely safe and well tolerated without evidence of enhanced or significant toxicity in the first 18 patients evaluated on the study. Accrual in this study has progressed to Stage 2 for the CPI naïve cohort and is ongoing in Stage 1 for the CPI refractory cohort. The full data set can be found under abstract number 157 at the virtual poster library, here.

Receipt of preliminary results are not necessarily indicative of the final-results of the Phase 2 trial studying PDS0101 in combination with KEYTRUDA for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

"We are encouraged by the preliminary safety data of PDS0101 in combination with KEYTRUDA for patients with recurrent or metastatic HPV16-positive head and neck cancer," commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "These data and the preliminary efficacy data continue to support the unique combination of safety and potency of our novel Versamune platform."

In addition to the ongoing VERSATILE-002 Phase 2 trial, PDS Biotech is conducting another Phase 2 clinical study in both second-and third-line treatment for multiple advanced HPV-associated cancers with the National Cancer Institute (NCI) (NCT04287868). A third Phase 2 clinical trial, IMMUNOCERV (NCT04580771), in first-line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center. In addition, the Company recently announced a fourth Phase 2 trial with Mayo Clinic to study PDS0101 with and without KEYTRUDA prior to surgery in locally advanced HPV-associated oropharyngeal cancer (NCT05232851).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On February 24, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported financial results for the fourth quarter and full-year of 2021 (Press release, Pacira Pharmaceuticals, FEB 24, 2022, View Source;991.htm [SID1234609030]).

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"The acquisition of Flexion Therapeutics combined with record EXPAREL sales resulted in a pivotal year for Pacira, allowing us to enter 2022 in the strongest financial position in our company’s history," said David Stack, chairman and chief executive officer of Pacira. "Despite challenges in the marketplace due to COVID-19, we continue to deliver strong results and remain bullish in our long-term expectations for growth."

"We were delighted to recently achieve a significant milestone as we marked our ten millionth patient treated with EXPAREL since launch. Further energized by this accomplishment, we remain committed to ongoing innovation in all areas of our business including new indications, line extensions, and design improvements to better serve patients and the healthcare providers who treat them while remaining at the forefront of the non-opioid pain management field."

2021 Full-Year and Fourth Quarter Financial Highlights

Full-year revenues of $541.5 million and fourth quarter revenues of $159.2 million.
Full-year GAAP net income of $42.0 million or $0.95 per share (basic) and $0.92 (diluted).
Fourth quarter GAAP net loss of $5.1 million or $0.12 per share (basic and diluted).
Full-year adjusted EBITDA of $204.0 million and fourth quarter adjusted EBITDA of $69.3 million.
Recent Business Highlights

New EXPAREL Patents. Pacira recently received Notices of Allowance from the United States Patent and Trademark Office for four EXPAREL patents that have been examined and will issue. Two patents claim chemical composition of EXPAREL and two claim product-by-process. After issuance, Pacira will submit these patents for listing in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). After listing, the Orange Book will have a total of six EXPAREL patents each with an expiration date of January 22, 2041.
$375 Million Term Loan B Facility. In December 2021, Pacira entered into a $375 million Senior Secured Term Loan B Facility. The company believes this successful debt offering validates its financial strength.
Completion of Flexion Therapeutics Acquisition. In November 2021, Pacira expanded its leadership position in non-opioid pain management with the acquisition of Flexion Therapeutics. With the closing, Pacira added ZILRETTA (triamcinolone acetonide extended-release injectable suspension) to its commercial offering. ZILRETTA is the first and only FDA-approved treatment for osteoarthritis (OA) knee pain utilizing extended-release microsphere technology.
Fourth Quarter 2021 Financial Results

Total revenues were $159.2 million in the fourth quarter of 2021, a 22% increase over the $131.0 million reported for the fourth quarter of 2020.
EXPAREL net product sales were $139.9 million in the fourth quarter of 2021, a 12% increase over the $125.3 million reported for the fourth quarter of 2020.
ZILRETTA net product sales were $12.7 million in the fourth quarter of 2021. The company began recognizing ZILRETTA sales upon completing its acquisition of Flexion in November 2021.
Fourth quarter 2021 iovera° net product sales were $4.9 million, a 102% increase versus the $2.4 million reported in the fourth quarter of 2020.
Total operating expenses were $155.0 million in the fourth quarter of 2021, compared to $112.2 million in the fourth quarter of 2020. The fourth quarter of 2021 included $40.7 million of acquisition-related charges, product discontinuation and other, primarily driven by $39.2 million of severance and other employee related costs, investment banking, legal and other professional fees, third-party services and other one-time charges associated with the acquisition of Flexion. The fourth quarter of 2021 also included $5.7 million of amortization for acquired intangible assets associated with the acquisition of Flexion.
Research and development (R&D) expenses were $15.5 million in the fourth quarter of 2021, compared to $15.3 million in the fourth quarter of 2020. The company’s R&D expenses included $5.3 million and $5.2 million of product development and manufacturing capacity expansion costs in the fourth quarters of 2021 and 2020, respectively.
Selling, general and administrative (SG&A) expenses were $52.2 million in the fourth quarter of 2021, compared to $52.8 million in the fourth quarter of 2020.
GAAP net loss was $5.1 million, or $0.12 per share (basic and diluted), in the fourth quarter of 2021, compared to GAAP net income of $14.5 million, or $0.33 per share (basic) and $0.32 per share (diluted), in the fourth quarter of 2020.
Non-GAAP net income was $44.4 million, or $0.99 per share (basic) and $0.97 per share (diluted), in the fourth quarter of 2021, compared to non-GAAP net income of $38.8 million, or $0.89 per share (basic) and $0.87 per share (diluted), in the fourth quarter of 2020.
Adjusted EBITDA was $69.3 million in the fourth quarter of 2021, a 61% increase over $42.9 million in the fourth quarter of 2020.
Pacira had 44.6 million basic weighted average shares of common stock outstanding in the fourth quarter of 2021.
For non-GAAP measures, Pacira had 45.5 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2021.
Full-Year 2021 Financial Results

Total revenues were $541.5 million in 2021, a 26% increase over the $429.6 million reported in 2020.
EXPAREL net product sales were $506.5 million in 2021, a 23% increase over the $413.3 million reported in 2020.
ZILRETTA net product sales were $12.7 million in 2021. The company began recognizing ZILRETTA sales upon completing its acquisition of Flexion in November 2021.
Full-year iovera° net product sales were $16.2 million, an 83% increase over the $8.8 million reported in 2020.
Total operating expenses were $451.6 million in 2021, compared to $383.3 million in 2020. 2021 included $42.9 million of acquisition-related charges, product discontinuation and other, primarily driven by $40.2 million of severance and other employee related costs, investment banking, legal and other professional fees, third-party services and other one-time charges associated with the acquisition of Flexion. 2021 also included $5.7 million of amortization for acquired intangible assets associated with the acquisition of Flexion.
R&D expenses were $55.5 million in 2021, compared to $59.4 million in 2020. The company’s R&D expenses include $19.4 million and $23.5 million of product development and manufacturing capacity expansion costs in 2021 and 2020, respectively.
SG&A expenses were $199.3 million in 2021, compared to $193.5 million in 2020.
GAAP net income was $42.0 million, or $0.95 per share (basic) and $0.92 per share (diluted) in 2021, compared to GAAP net income of $145.5 million, or $3.41 per share (basic) and $3.33 per share (diluted) in 2020. Included in GAAP net income in 2020 was a $126.6 million income tax benefit related to the release of a valuation allowance on deferred tax assets.
Non-GAAP net income was $136.7 million, or $3.09 per share (basic) and $3.00 per share (diluted), in 2021, compared to non-GAAP net income of $96.6 million, or $2.26 per share (basic) and $2.21 per share (diluted), in 2020.
Adjusted EBITDA was $204.0 million in 2021, a 81% increase over $112.6 million in 2020.
Pacira had 44.3 million basic and 45.6 million diluted weighted average shares of common stock outstanding in 2021.
See "Non-GAAP Financial Information" below.

2022 Financial Guidance

The company’s product sales continue to be impacted by COVID-19, which has caused significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Given the continued uncertainty around COVID-19 and the pace of recovery for the elective surgery market, the company is currently not providing revenue or gross margin guidance. To provide greater transparency, Pacira is reporting monthly intra-quarter unaudited net product sales for EXPAREL and iovera° until it has gained enough visibility around the impacts of COVID-19. Pacira is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. Pacira is currently not reporting preliminary monthly ZILRETTA net product sales as the required adjustments for certain product rebate programs are calculated after the end of the quarter.

Today the company is providing full-year 2022 operating expense guidance as follows:

Non-GAAP R&D expense of $75 million to $85 million;
Non-GAAP SG&A expense of $220 million to $230 million; and
Stock-based compensation of $40 million to $45 million.
See "Non-GAAP Financial Information" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Thursday, February 24, 2022, at 8:30 a.m. ET. To participate in the conference call, dial 1-888-771-4371 and provide the passcode 50282786. International callers may dial 1-847-585-4405 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay of the webcast will be available on the Pacira website for approximately two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP net income per common share, non-GAAP cost of goods sold, non-GAAP research and development (R&D) expense, non-GAAP selling, general and administrative (SG&A) expense, EBITDA (earnings before interest, taxes, depreciation and amortization) and adjusted EBITDA, because these non-GAAP financial measures exclude the impact of items that management believes affect comparability or underlying business trends.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to estimate its future cost of goods sold, R&D expense and SG&A expense outlook for 2022 and to better analyze its financial results and help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance of Pacira and its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures.

On February 24, 2022 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported that a poster will be presented at the 17th Annual HD Therapeutics Conference (hosted by CHDI Foundation) with its collaborator, Dr. Amber Southwell, on Wednesday, March 2, 2022 (Press release, Vaccinex, FEB 24, 2022, View Source [SID1234609029]). Please see Presentation details below:

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CHDI Conference

Date: March 2, 2022

Time: 1:00 p.m. PST/4:00 p.m. EST: Poster Section

Poster Title: Combination anti-semaphorin 4D immunotherapy and ASO-mediated total HTT lowering provide benefit beyond either individual therapy in humanized HD mice

Presenter:

Amber Southwell, Ph.D., Assistant Professor,
Burnett School of Biomedical Sciences
University of Central Florida, Orlando, FL

Add to calendar: View Source

Program Link: CHDI Meeting Information
For more information about the CHDI Foundation, please refer to the Foundation website.