On November 1, 2022 Helix BioPharma Corp. (TSX: "HBP"), ("Helix" or the "Company"), a clinical-stage biopharmaceutical company developing unique therapies in the field of immuno-oncology based on its proprietary technological platform DOS47, reported financial results for the 2022 fiscal year ended July 31, 2022 (Press release, Helix BioPharma, NOV 1, 2022, View Source [SID1234622786]).

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OVERVIEW
The Company reported a net loss and total comprehensive loss of $6,563,000 or $0.04 loss per common share for fiscal 2022 (2021-$8,038,000 or $0.06 loss per common share).

Clinical development LDOS47 in lung cancer
 The Phase I study combination therapy in lung cancer (LDOS001) was completed and the final clinical trial report issued in December 2021. A manuscript was accepted for publication in Journal of Thoracic Oncology Clinical and Research Reports on September 2nd, 2022. A pre-print can be found here: View Source(22)00132-1/fulltext#relatedArticles.
 The Phase II study of combination therapy in lung cancer (LDOS003) was halted in the dose escalation portion of the study in 2020 at the height of pandemic lockdown and the final abbreviated clinical trial report has been further delayed amidst war in Ukraine where all subjects were recruited. A final effort is being made in an attempt to retrieve any data that is salvageable and conclude the study.
 Another important aspect of the development of the LDOS47 platform is the combination with chemo-and/or immuno-therapy, that may boost the utility of the platform. The Company has engaged several key opinion leaders to evaluate the feasibility of such combinations and aims to develop a develop a roadmap by the second quarter of 2022.

LDOS47 in pancreatic cancer The Company’s Phase I-b/II combination trial in pancreatic cancer (LDSOS006) continues to recruit patients. We recently applied to the U.S. Food and Drug Administration for a revision to the clinical study protocol to extend the number of treatment cycles for those patients where the benefits outweigh the risks. We remain committed to this study. The first dosing cohort was successfully completed and now the second dosing cohort is also nearing completion.

Corporate development
 On August 19, 2021, the Company announced that Dr. Krzysztof Saczek had been appointed as a member of the board of directors of the Company (the "Board") effective immediately in connection with the resignation of Mr. Heman Chao as CEO, CSO and as a member of the Board. Mr. Chao’s resignation became effective on September 1, 2021 and Mr. Chao assumed the position of Chair of the Company’s Scientific Advisory Board on the same date.

 On March 11, 2022, the Company closed a private placement financing for gross proceeds of $1,001,000 from the issuance of 3,850,000 common share at a price of $0.26 per common share. On April 21, 2022, the Company closed a private placement financing for net proceeds of $2,002,000 from the issuance of 7,700,000 common shares at a price of $0.26 per common share.

 On April 13, 2022, the Company announced that it has received conditional approval from the Toronto Stock Exchange to extend its previously announced Early Warrant Exercise Incentive Program from April 28, 2022, to May 31, 2022. The Incentive Program is a period during which holders of the Company’s eligible common share purchase warrants ("Eligible Warrants") may take advantage of a temporary reduction in the exercise price of the Eligible Warrants to a price of C$0.26. The Eligible Warrants include an aggregate of 49,806,469 warrants that if exercised at the Incentive Exercise Price will result in the Company receiving gross proceeds of up to $12,949,682. During the year ended July 31, 2022, 12,346,938 warrants were exercised for a total subscription amount of $3,210,204.

 On April 18, 2022, the Company announced that Artur Gabor has been appointed as the Company’s Chief Executive Officer with immediate effect. The Company also announced the addition of three new members to its Board of Directors: Jerzy Leszczyński, Christopher Maciejewski and Jacek Antas have been appointed to the Board effective immediately.  On May 11, 2021, the Company entered into a definitive convertible security funding agreement (the "Lind Agreement") with Lind Global Macro Fund, LP, a New York based institutional investment fund managed by The Lind Partners, LLC (collectively "Lind"). The Company closed the first tranche under the Lind Agreement on May 13, 2021 for gross proceeds of $3,500,000 (the "First Tranche"). See Liquidity and Capital Resources section below.

 On May 18, 2022, the Company announced the appointment of Mr. Hatem Kawar as the Company’s Chief Financial Officer effective immediately.

 On August 9, 2022, the Company announced that it has entered into a two-year scientific collaboration agreement ("Agreement") with University Hospital Tubingen (Germany) to assess the therapeutic response of L-DOS47 in several cancer models expressing CEACAM6, with advanced preclinical metabolic imaging.

 On August 30, 2021, the Company announced that it had completed the buyback of the outstanding amount of the convertible security funding agreement with Lind Global Macro Fund, LP. The Company entered into the Agreement with Lind in May 2021 and closed the first tranche under the Agreement for gross proceeds of $3,500,000 shortly thereafter. The Company has now bought back the amount outstanding of the Convertible Security under the Agreement, which is C$2,061,875.

 On September 1, 2022, the Company announced the appointment of Dr. Gabrielle M Siegers, MA, Ph.D., as the Head of R&D based out of the Company’s lab in Edmonton.

 On Sep 12, 2022, the Company applied to the TSX to price protect a proposed $5 million financing of common shares at a price of $0.18 per share. The TSX granted a price protection letter on Sep 14, 2022, and the conditional approval of the placement on Sep 26, 2022. The closing of the private placement is expected by November 1, 2022. As of October 31, 2022, the Company has received a total of $4,644,000 in subscription receipts related to this financing.

 On October 3, 2022, the Company announced the appointment of Dr. Frank Gary Renshaw, as the Chief Medical Officer. Research and development Research and development expenses for fiscal 2022 totalled $4,544,000 (2021-$5,880,000). The following table outlines research and development costs and investment tax credits for the Company’s significant research and development projects for the fiscal years ended July 31: Research and development expenditures for the year ended July 31, 2022, when compared to the year ended July 31, 2021, were lower by $1,318,000. The decrease in spending is mainly the result of lower expenditures associated with research and development activities by 29% partially offsetting the increases in consulting services and stockbased compensation, which were higher due to expense of stock options granted to consultants. When compared to the year ended July 31, 2021, the Company also spent less on salaries and benefits by $195,000 or15% while consulting and stock-based compensation were higher by $943,000.

The Company hired biotechnology consultants to assess the Company’s drug product candidate with a focus on identifying value propositions and positioning strategies that would enable clinical adoption of L-DOS47. Operating, general and administration Operating, general and administration expenses for fiscal 2022 totalled $1,496,000 (2021-$3,251,000). Operating, general and administration expenditures for the year ended July 31, 2022, when compared to the year ended July 31, 2021, were lower by $1,756,000 or 54%. Since May 2022. The Company has made significant efforts to control and reduce its overheads expenditures. This included closing its headquarters at Richmond Hill Ontario and moving it to Grove Corporate Services offices "(Grove") in downtown Toronto.

The Company hired Grove to perform accounting and corporate secretarial services following the resignation of its previous CFO in May 2022. The savings apply to various activities including salaries, rent, legal, and other operational expenditures. Further measures are being taken which will result in more reductions in the next quarter. Some expenditures in the comparative period relates to the Company’s attempt to raise additional capital as part of a qualifying transaction to list its common shares on a U.S. stock exchange, the termination of an investor relations agreement with ACM Alpha Consulting Management EST ("ACMest") and stock-based compensation expenses of stock options granted to directors and consultants. Several factors materialized that resulted in the Company abandoning its plans to list on a U.S. stock exchange. These include but are not limited to the increase in the percentage ownership of the Common Shares by new insiders; a decline in the price of the Common Shares making it extremely challenging for the Company to leverage the Multijurisdictional Disclosure System; and the resignation of the Company’s previous auditors.

LIQUIDITY AND CAPITAL RESOURCES As at July 31, 2022 the Company had working capital of $283,000 (2021-$144,000), shareholders’ equity of $319,000 (2021 – shareholders’ deficit of 1,393,000) and a deficit of $195,117,000 (2021-$188,554,000). On March 11, 2022, the Company closed a private placement financing for gross proceeds of $1,001,000 from the issuance of 3,850,000 common share at a price of $0.26 per common share. On April 21, 2022, the Company closed a private placement financing for net proceeds of $2,002,000 from the issuance of 7,700,000 common shares at a price of $0.26 per common share. On April 13, 2022, the Company announced that it has received conditional approval from the Toronto Stock Exchange to extend its previously announced Early Warrant Exercise Incentive Program from April 28, 2022, to May 31, 2022.

The Incentive Program is a period during which holders of the Company’s eligible common share purchase warrants ("Eligible Warrants") may take advantage of a temporary reduction in the exercise price of the Eligible Warrants to a price of C$0.26. The Eligible Warrants include an aggregate of 49,806,469 warrants that if exercised at the Incentive Exercise Price will result in the Company receiving gross proceeds of up to $12,949,682. During the year ended July 31, 2022, 12,346,938 warrants were exercised for a total subscription amount of $3,210,204. On August 30, 2022, the Company announced that it had completed the buyback of the outstanding amount of the convertible security funding agreement with Lind at a cost of C$2,061,875. In May 2021, the Company initially issued a convertible security with a two-year term and a face value of $4,112,500 and issued an aggregate of 1,957,056 warrants exercisable into Common Shares for a period of 48 months at an exercise price of $1.0283 per Common Share.

As of July 31, 2022, Lind has converted an aggregate of $1,233,750 of the face value of the Convertible Security issued under the first tranche into an aggregate of 4,345,087 common of the Company at an average deemed price of $0.243 per common share. In August 2022, Lind further converted $405,625 of face value into an aggregate 2,507,329 shares at an average deemed price of $0.1618 per common share. On September 12, 2022, the Company applied to the TSX to price protect a proposed $5 million financing of common shares at a price of $0.18 per share. The TSX granted a price protection letter on September 14, 2022, and the conditional approval of the placement on September 26, 2022.

As of October 31, 2022, the Company has received a total of $4,644,000 in subscription receipts related to this financing. In order for the Company to advance the currently planned preclinical and clinical research and development activities, its collaborative scientific research programs and pay for its overhead costs, the Company will need to raise approximately $11,000,000 through to the end of fiscal 2024. The Company projects an average monthly fixed overhead spend of approximately $250,000. This amount does not include the costs related to any of the Company’s third-party activities such as clinical studies, collaborative research activities and contract manufacturing. The Company currently has three clinical studies (see Research and Development Activities above for additional information) in various stages.

The Company has completed the clinical study report for LDOS001 and submitted a final annual report to the FDA in April 2022 and update the result into the www.clinicaltrials.gov portal in June 2022. The Company is forecasting approximately $10,000 to finalize reporting. The Company received IND approval by the FDA to conduct a Phase I-b/II study (LDOS006) in the U.S., L-DOS47 in combination with doxorubicin, for previously treated advanced pancreatic cancer. Patient enrollment commenced December 2019. COVID-19 impacted patient enrollment resulting in the Company adding two additional clinical sites this year. The Company is forecasting a cost of approximately $4,650,000 through to December 2024 to complete both the Phase I-b and Phase II portion of the trial. Certain conditions need to be achieved in order for the Company to be able to progress through to the Phase II portion of the trial. Of the forecasted $4,650,000, the portion attributable to the Phase II is estimated to be approximately $2,600,000.

The Company is also forecasting $1,600,000 towards pre-clinical studies which are to be carried out in cooperation with its partners at Tubingen University and H. Lee Moffitt Cancer Center and Research Institute Inc. The Company’s consolidated financial statements, management’s discussion and analysis and annual information form will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website at www.helixbiopharma.com.

On November 1, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported at its Capital Markets Day an update on how the Company is taking meaningful steps to transform biologics manufacturing to enable global access (Press release, Evotec, NOV 1, 2022, View Source [SID1234622761]).

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The programme entitled: "Paradigm shift in Biologics" will take place at its J.POD Redmond, WA (US) facility. In line with the theme, capital market participants and thought leaders will learn how Evotec’s subsidiary company, Just – Evotec Biologics, is taking meaningful strides to transform biologics manufacturing to expand global access to quality biotherapeutics in support of Evotec’s mission: "Together for medicines that matter".

The Capital Markets Day agenda will include a tour of Just – Evotec Biologics’ state-of-the-art cGMP biomanufacturing facility (J.POD) and presentations highlighting how the company is using its highly integrated AI/ML-based platforms in the areas of discovery, process development, and continuous manufacturing. In totality, participants will have a full understanding of how the company’s expertise and innovative technology will disrupt today’s market for biologics manufacturing.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "The biologics manufacturing industry has been entrenched in decades old technology, which has hampered global access to important biotherapeutics. Just – Evotec Biologics’ technology platforms unlock the potential of biologics for diseases affecting large and small patient populations and enables affordable commercialisation strategies for novel effective antibody combination therapies. This is what we mean by: Together for medicines that matter."

Dr Linda Zuckerman, EVP and Global Head of Biotherapeutics, stated: "We are well ahead of the curve and are implementing our continuous manufacturing for biotherapeutics. Combined with our AI/ML-based discovery and design capabilities, we are well positioned to fulfil our mission to expanded global access to biotherapeutics."

Just – Evotec Biologics, recently joined the U.S. Department of Defense’s ("DOD") Advanced Development and Manufacturing network of facilities, following a thorough vetting process that led to a contract worth up to $ 49.9 m for the rapid development of monoclonal antibody-based drug product prototypes.

Just – Evotec Biologics reported that it has been selected for a second award under the Accelerated Antibodies Program.

The company recently broke ground for a second biopharmaceutical manufacturing facility, J.POD Toulouse, France (EU), at Evotec’s Campus Curie. A clone of the Redmond facility, the Toulouse J.POD will bring advanced biomanufacturing to the EU.

Dr John Erickson, a veteran industry leader, stated: "There is a growing consensus in the industry that biopharmaceutical factories need to be smaller and more flexible. These goals are synergistic and I believe that integrated and continuous bioprocessing is a key enabler for both."

About the Capital Markets Day
Evotec hosts its Capital Markets Day on 02 November 2022, starting at 9.00 am PDT (12.00 pm EDT, 5.00 pm CET) with a site tour. The meeting will take place on site at Just – Evotec Biologics’ Redmond Facility, J.POD Redmond, WA (US). The presentation will be streamed via a live webcast starting at 11.00 am PDT (2.00 pm EDT, 7.00 pm CET) and a recording will be available on www.evotec.com the next day.

About Dr John Erickson
The son of a NASA engineer, Dr Erickson has always had a natural curiosity and passion for innovation. Dr Erickson received a BA in Biology and Chemistry from Amherst College and a MS in Chemical Engineering Practice and PhD in Chemical Engineering from MIT. He initially worked in industrial enzymology at Rhône-Poulenc before joining the biopharmaceutical industry. After joining GSK, he held a variety of roles in process development, project management, and manufacturing over 29 years. One of the highlights of that time was working with other industry colleagues on the A-mAb case study. Most recently, Dr Erickson served as Vice President, Biopharmaceutical and Steriles Manufacturing Science and Technology, where he was responsible for scientific oversight and support for commercial biopharmaceutical drug substance and sterile fill/finish of biopharmaceuticals and small molecules.

Dr Erickson started a consulting company in 2019. He has been consulting for the National Institute for Innovation in Manufacturing Biopharmacuticals ("NIIMBL"), a public/private partnership, since 2019 as a Senior Fellow and has been Acting Chief Technology Officer since 2020. At NIIMBL he applies his perspective and extensive industry experience to help ensure that NIIMBL investments are aligned with current industry needs; support the management of a portfolio of impactful projects; and help lead technology initiatives and projects that will benefit the biopharmaceutical manufacturing ecosystem.

On November 1, 2022 Chimeric Therapeutics (ASX: CHM, "Chimeric"), a clinical-stage cell therapy company and an Australian leader in cell therapy, reported that it has entered into a sponsored research agreement (SRA) with Case Western Reserve University (CWRU) to further advance Chimeric’s NK cell therapy portfolio (Press release, Chimeric Therapeutics, NOV 1, 2022, View Source [SID1234622760]).

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The research program at CWRU will be led by Dr David Wald, inventor of the CORE NK technology. Through this research collaboration, Dr Wald and his laboratory will work closely with Chimeric to advance multiple next-generation NK cell products through preclinical development, including CHM 0301 (Next-Generation CORE-NK Platform), CHM 1301 (Chlorotoxin CAR NK), CHM 2301 (CDH17 CAR NK), and CHM 3301 (undisclosed CAR NK).

Chimeric’s NK cell therapy portfolio foundational asset, CHM 0201 (CORE NK platform) was invented and developed by Dr Wald at Case Western. CHM 0201 was studied in a phase 1 clinical trial at Seidman Cancer Center in Ohio with promising outcomes that were published1 earlier this year. All key endpoints of the study were achieved, including safety with no graft versus host disease, cell persistence and cell expansion. In addition, an encouraging efficacy signal was demonstrated, particularly in blood cancers where all patients achieved disease control and one patient achieved a complete response that was sustained through to 15 months at time of study publication.

"With the encouraging clinical data seen with CHM 0201 (CORE NK cell platform) we are very excited to be enhancing our collaboration with Dr Wald and his team at Case Western. By building upon Dr Wald’s NK cell scientific experience and expertise we believe we will be able to advance NK cell therapies to benefit patients in multiple disease areas in the future" said Jennifer Chow, CEO and Managing Director Chimeric Therapeutics.

Dr Wald is an Associate Professor, Department of Pathology, School of Medicine, CWRU, a member of the Immune Oncology Program, Case Comprehensive Cancer Center, and the Associate Director for Basic Research, University Hospitals, Wesley Center for Immunotherapy.

Under the SRA, Chimeric receives the exclusive option to license intellectual property created For personal use only by CWRU as part of the sponsored research. The agreement is outcomes based on research aims for an initial period estimated to be two years, which may be extended by mutual agreement of the parties.

Investor webinar
Chimeric Therapeutics CEO and Managing Director Jennifer Chow, CMO Dr Jason B Litten and Dr David Wald will hold an investor webinar tomorrow, Thursday 3 November 2022 at 9am AEDT to elaborate on this announcement and take questions.

Click the link below to register: View Source

After registering, you will receive a confirmation email about how to join the webinar. A recording of the webinar will be available at the same link shortly after the conclusion of the session.

¹ ASX announcement, 7 March 2022

On November 1, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported that the company will host a webcast to share initial clinical data from its SB101 clinical study with SON-1010 in oncology patients (NCT05352750) and its SB102 clinical study with SON-1010 in healthy volunteers (NCT05408572) on Wednesday, November 2, 2022 at 8:30 am ET (Press release, Sonnet BioTherapeutics, NOV 1, 2022, View Source [SID1234622759]).

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Webcast presenters will include:
Richard Kenney, M.D., Chief Medical Officer
Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Office

The webcast at 8:30 am ET, with an accompanying presentation, will be accessible under News & Events, IR Calendar in the Investors section of the company’s website. The archived audio webcast will be available on Sonnet’s website following the call.

This first-in-human study is primarily designed to evaluate the safety of multiple ascending doses of SON-1010 in cancer patients and will be conducted at several sites across the United States. While the optimal dose is unknown at this stage, the potential to target tumors, the extended PK mechanism and our preclinical data suggest the therapeutic dose may be lower compared to native human IL-12. The study, utilizing a standard 3+3 oncology design in at least five cohorts, should establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) using monthly subcutaneous injections of SON-1010. The primary endpoint explores the safety and tolerability of SON-1010, with key secondary endpoints intended to measure PK, PD, immunogenicity and anti-tumor activity. This study will form the basis for potential combinations with other types of immunotherapies and the future development of bispecific candidates using the FHAB platform.

About the SB102 Phase 1 Trial

The SB102 study is designed to robustly evaluate the safety, PK and PD of single ascending doses of SON-1010, using larger groups of healthy volunteers, and is being conducted at a single site in Australia. The study is done in a blinded fashion, comparing a single dose of SON-1010 to placebo utilizing five cohorts. Both PK and PD will be closely followed during dose escalation in this double-blind, placebo-controlled study, along with an assessment of the cellular immune responses at each dose using sophisticated fluorescence activated cell sorting (FACS) analysis. The primary endpoint explores the safety and tolerability of SON-1010, with key secondary endpoints intended to measure PK, PD and immunogenicity.

On November 1, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the third quarter ended September 30, 2022 (Press release, Acorda Therapeutics, NOV 1, 2022, View Source [SID1234622758]).

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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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"The AMPYRA arbitration ruling was a major milestone for Acorda, providing a significant cash infusion and, even more importantly, the ability for us to obtain AMPYRA supply at far more competitive rates. We expect this to significantly enhance the value of this product to the company," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We are also pleased that INBRIJA continued to recover from the impact of the pandemic surge in the first quarter of this year. Independent sources show that INBRIJA is the market leader for on-demand treatments in Parkinson’s disease, with a 67% share. Our highest priority now is to increase the size of the overall on-demand market by educating health care professionals and people with Parkinson’s about how important it is to address OFF periods."

Regarding the Special Meeting of Stockholders, Dr. Cohen added, "The board of directors and I urge all shareholders to vote FOR Proposal 2, to authorize the reverse stock split, in advance of the meeting on November 4. This is critical to ensure that we are not de-listed from Nasdaq, which could hamper our ability to execute on our business plan and could result in our being in default to our debtholders."

Third Quarter 2022 Financial Results
For the quarter ended September 30, 2022, the Company reported INBRIJA worldwide net revenue of $8.8 million, of which $7.8 million was derived from sales in the U.S., a 1% increase compared to the same quarter in 2021. The Company also reported Ex-U.S. INBRIJA net revenue of $1.0 million in the third quarter related to the Esteve launch in Germany.

For the quarter ended September 30, 2022, the Company reported AMPYRA net revenue of $21.1 million, compared to $20.0 million for the same quarter in 2021. As previously disclosed, AMPYRA lost its exclusivity and generics entered the market in 2018, and the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended September 30, 2022 were $1.4 million, including negligible share-based compensation expenses, compared to $1.9 million, including $0.2 million of share-based compensation for the same quarter in 2021.

Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2022 were $23.0 million, including $0.4 million of share-based compensation, compared to $29.6 million, including $0.6 million of share-based compensation for the same quarter in 2021.

Change in fair value of derivative liability for the quarter ended September 30, 2022 was negligible, compared to $(0.3) million for the same quarter in 2021.

Provision for income taxes for the quarter ended September 30, 2022 was $1.4 million, compared to a benefit from income taxes of $3.1 million for the same quarter in 2021.

The Company reported a GAAP net loss of $13.9 million for the quarter ended September 30, 2022, or $0.57 per diluted share. GAAP net loss in the same quarter of 2021 was $27.1 million, or $2.43 per diluted share.

Non-GAAP net loss for the quarter ended September 30, 2022 was $13.3 million, or $0.55 per diluted share. Non-GAAP net loss in the same quarter of 2021 was $15.9 million, or $1.43 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, changes in the fair value of derivative liability related to our 2024 convertible senior secured notes, and expenses that pertain to non-routine corporate restructurings. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At September 30, 2022, the Company had cash, cash equivalents, and restricted cash of $34.2 million, compared to $65.2 million at year end 2021. Restricted cash includes $12.4 million in escrow related to the semi-annual interest payment to the holders of its 6.00% convertible senior secured notes (Convertible Notes). Cash at September 30, 2022 does not include the $16.5 million arbitration award, which amount was received in October 2022.

Special Meeting of Stockholders November 4, 2022
Acorda will hold a Special Meeting of Stockholders on Friday, November 4 (the Special Meeting). Acorda’s CEO, board, and the three leading proxy advisory firms recommend that shareholders vote FOR both of the following proposals to be addressed at the meeting:

Reverse Stock Split Proposal: To authorize Acorda’s Board of Directors to implement a reverse stock split of its common stock at a ratio of any whole number in the range of 1-for-2 to 1-for-20 within one year of the Special Meeting. This proposal is critical to get Acorda’s stock price above $1.00 per share in order to avoid being delisted from Nasdaq. Delisting could put the company in default to the holders of its Convertible Notes, potentially requiring Acorda to liquidate or file for bankruptcy. In a reverse stock split, shareholders would hold the exact same percentage of Acorda stock, with the same value as they did prior to the split.
Adjournment Proposal: To approve one or more adjournments of the Special Meeting to a later date or dates, if necessary or appropriate, to solicit additional proxies if there are insufficient votes to approve the Reverse Stock Split Proposal at the time of the Special Meeting, or in the absence of a quorum.
AMPYRA Arbitration
On October 16, 2022 we announced that an arbitration panel issued a final decision in a dispute with Alkermes PLC (Nasdaq: ALKS) regarding licensing royalties relating to AMPYRA (dalfampridine). Acorda was awarded $15 million plus prejudgment interest of $1.5 million from Alkermes. In addition, as a result of the panel’s ruling, Acorda will no longer have to pay Alkermes any royalties on net sales for license and supply of AMPYRA, and Acorda is now free to use alternative sources for supply of AMPYRA, which it has already secured.

2022 – 2027 Financial Guidance
For the full year 2022, Acorda continues to expect AMPYRA net revenue to be $68 – $78 million, and adjusted operating expenses to be $110 – $120 million. The financial guidance provided below includes non-GAAP projections of adjusted operating expenses (adjusted OPEX) and adjusted earnings before income taxes depreciation and amortization (adjusted EBITDA), as described below under "Non-GAAP Financial Measures."

Webcast and Conference Call
The Company will host a webcast in conjunction with its third quarter update and financial results today at 4:30 p.m. ET.

To participate in the Webcast, please use the following registration link:

View Source
If you register for the Webcast, you will have the opportunity to submit a written question for the Q&A portion of the presentation. After you have registered, you will receive a confirmation email with the Webcast details. On the day of the Webcast, you will receive an email 2 hours prior to the start of the Webcast with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on November 1, 2022 until 11:59 p.m. ET on December 1, 2022. To access the replay, please dial 1 866 813 9403 (domestic) or +44 204 525 0658 (international); reference code 945092. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Non-GAAP Financial Measures
This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP) and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net income (loss), adjusted to exclude the items below, and has provided 2022-2027 adjusted operating expense and adjusted EBITDA guidance on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of non-GAAP net income (loss), when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra royalty monetization and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) expenses that pertain to corporate restructurings which are not routine to the operation of the business, and (v) changes in the fair value of derivative liability relating to the 2024 convertible senior secured notes, which is a non-cash charge and not related to the operation of the business. The Company believes its non-GAAP net income (loss) measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding the Company’s projected operating performance. In addition, management uses this non-GAAP financial measure to establish budgets and operational goals, to manage the Company’s business, and to evaluate its performance.

In addition to non-GAAP net income (loss), we have provided non-GAAP projections of adjusted OPEX and adjusted EBITDA. Adjusted OPEX includes (i) research and development expenses and (ii) selling, general, and administrative expenses and excludes (i) costs of goods sold, (ii) amortization of intangible assets, (iii) change in fair value of derivative liability, and (iv) change in fair value of acquired contingent liability. Adjusted EBITDA is GAAP net income (loss) before income taxes excluding (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) interest due on our convertible debt, (iii) non-cash interest charges related to the accounting for our convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra royalty monetization and acquired Biotie debt, (iv) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (v) expenses that pertain to corporate restructurings which are not routine to the operation of the business, and (vi) changes in the fair value of derivative liability relating to the 2024 convertible senior secured notes, which is a non-cash charge and not related to the operation of the business. We are unable to reconcile these forward-looking non-GAAP measures to GAAP due to the forward-looking nature of the adjustments that are needed to determine this information, which includes information regarding future compensation charges, future changes in the market price of our common stock, and changes in the fair value of derivative and contingent liabilities, none of which are available at this time.

Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP, and the calculation of the non-GAAP financial measures included herein may differ from similarly titled measures used by other companies. The Company believes that the presentation of these non-GAAP financial measures, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because it excludes (i) expenses that pertain to corporate restructurings not routine to the operation of our business, (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock, and (iii) other items as set forth above that are not ascertainable at the present time. We believe these non-GAAP financial measures help indicate underlying trends in the Company’s business and are important in comparing current results with prior period results and understanding expected operating performance. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and evaluate its performance.