On March 24, 2022 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, reported financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update (Press release, Ocuphire Pharma, MAR 24, 2022, View Source [SID1234610922]).

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"2021 proved to be a highly productive year for Ocuphire with 2022 setting up to be a more transformative year given our series of late-stage data read-outs in MIRA, LYNX and ZETA trials throughout the year, ending with our first planned NDA filing. We have an ambitious vision in ophthalmology targeting highly prevalent refractive and diabetic retinal diseases with our 2 lead small molecule drug candidates," said Mina Sooch, MBA, Founder and CEO of Ocuphire Pharma. "We are pleased to rapidly exceed enrollment in and complete 4 clinical trials across Nyxol and APX3330 in the first months of 2022. At our R&D Day in January, we reported for the first time positive Phase 2 results in presbyopia for Nyxol as a single-agent. With this new chronic opportunity for Nyxol alone as a pupil modulation agent, we can potentially realize synergies in presbyopia and NVD patients. We recently held a FDA Type-C meeting and gained clear guidance for the VEGA Phase 3 presbyopia program, for which we plan to initiate in mid-2022. With the successful enrollment of the 24-week study for our retinal candidate APX3330 and the continued favorable systemic and ocular safety profile that we shared at our recent R&D Day, we are also excited to lead the retinal landscape with an oral option for diabetic retinopathy patients and report our topline data from our placebo-controlled, double-masked, Phase 2b ZETA-1 trial in the second half of 2022."

Jay Pepose, MD, PhD, Ocuphire’s Medical Advisor and Board Member stated, "Ocuphire’s product candidates, if approved, would give eye care practitioners the ability to enhance their patients’ vision and overall experience. As a refractive surgeon, I am particularly excited about Nyxol for RM because there is currently no FDA approved commercially available product to treat this major clinical need and patient complaint. For presbyopia, I am impressed by Nyxol’s favorable tolerability profile and durable near vision improvements for at least 12 hours across a broad age of patients (40 to 64 years old) in the recent VEGA-1 Phase 2 trial. Nyxol is differentiated from the other miotics in the presbyopia landscape by its mechanism of action inhibiting the iris dilator muscle to achieve an optimal pupil size. Since Nyxol does not engage the iris sphincter or ciliary muscle, as a single drop, this may become a viable treatment option for presbyopia patients with high myopia, for whom miotics are contraindicated because of the risk of retinal detachment."

Cam Gallagher, Chairman of the Board for Ocuphire added, "In the past year, Ocuphire has elevated its profile within the ophthalmology and optometry medical community and we are delighted to have expanded our prestigious Medical Advisory Board to over 15 refractive and retinal KOLs. The team led by Mina has executed and delivered on several key clinical development milestones and set the momentum for a catalyst-rich 2022 that has the potential to build significant value for our company and shareholders."

Key Anticipated Future Milestones

Reversal of Mydriasis (RM):
MIRA-3: Report topline results from the Phase 3 MIRA-3 registration trial at the end of 1Q 2022
MIRA-4: Report topline results from pediatric safety trial in 2Q 2022
New Drug Application (NDA): If the results are positive from the ongoing MIRA trials, expect to file an NDA with the FDA for Nyxol in RM indication in late 2022 with potential launch as first dilation reversal drop in 2H 2023
Presbyopia: Initiate VEGA Phase 3 program in mid-2022 investigating Nyxol alone and Nyxol with 0.4% LDP as adjunctive treatment; and, if successful, expect to file an NDA in 2023
Night Vision Disturbances (NVD): Report top-line results in 2Q 2022 from the Nyxol Phase 3 LYNX-1 trial
Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME): Report top-line results from the APX3330 Phase 2b ZETA-1 trial in 2H 2022
Fourth Quarter and Recent Business Highlights

Corporate

In January 2022, the Company held an Investor R&D Day webinar that featured six ophthalmic Key Opinion Leaders (KOLs): Jay Pepose, MD, PhD, James Katz, MD and Mitchell Jackson, MD from refractive surgery, Paul Karpecki, OD from optometry, and David Boyer, MD and Peter Kaiser from retina practice areas who discussed the unmet needs in RM, presbyopia and DR being addressed by Ocuphire’s two late-stage clinical drug assets, Nyxol and APX3300. A replay of the event can be found on the company’s corporate website here.
In December 2021, the Company strengthened its Medical Advisory Board with the addition of six world-class KOLs: David Brown, MD, FACS; David Lally, MD; Y. Ralph Chu, MD; James Katz, MD; Mitchell Jackson, MD; and Douglas Devries, OD.
Clinical Development

In March 2022, the Company completed enrollment of 103 (target of 80-100) diabetic retinopathy patients in the ZETA-1 Phase 2b trial of first-in-class oral APX3330. Masked safety data from the trial, announced during the R&D Day event in January 2022, demonstrated a favorable safety profile, consistent with prior studies with additional exposure data in diabetic patients with retinal disease.
In March 2022, the Company completed enrollment in MIRA-4 Trial for Nyxol in RM by enrolling 23 healthy (target of 20) pediatric subjects ages 3-11 years.
In February 2022, the Company completed enrollment in MIRA-3 Pivotal Phase 3 Trial for Nyxol in RM, surpassing its enrollment target of 330 with 368 patients ages 12 years and over.
In February 2022, Ocuphire held a Type-C meeting with the FDA from which it obtained guidance regarding the design of pivotal studies and clarification of the CMC and other data requirements for filing an NDA to seek approvals of Nyxol for the treatment of presbyopia, both as a single agent and with LDP as adjunct eye drops. This represents our third Type-C or Type-B End of Phase 2 meeting with FDA for the Nyxol program across indications.
In January 2022, the Company completed enrollment of LYNX-1 Phase 3 Trial investigating Nyxol for the treatment of night vision disturbances (NVD) in 145 patients (target of 140).
In January 2022, the Company announced new positive data from the VEGA-1 Phase 2 trial for Nyxol as a single agent in presbyopia, showing that one drop of Nyxol had statistically significant improvement in efficacy and long durability compared to placebo at 12 hours post-dosing. The Company plans to proceed with the Phase 3 VEGA program to potentially support 2 NDAs: Nyxol as a single drop and Nyxol with low-dose pilocarpine (LDP) as adjunctive treatment.
Presentations, Publications, and Conferences

In February 2022, David Boyer, MD, presented at the Angiogenesis, Exudation, and Degeneration Conference, highlighting the favorable safety data from the ongoing ZETA-1 Phase 2 trial of APX3330 in DR.
In February 2022, Inder Paul Singh, MD, presented at the Cataract Surgery: Telling It Like It Is Conference in Orlando. Dr. Singh presented the positive results from the completed VEGA-1 Phase 2 trial of Nyxol in presbyopia as a single agent and in combination with adjunctive LDP.
In January 2022, Mina Sooch, Founder and CEO participated in the panel discussion titled "The Role of Gender Equality in Changing the Life Sciences Investment and Innovation Landscape" at the 11th LifeSci Partners Corporate Access Event.
In November 2021, clinical data on Nyxol and APX3330 were presented at poster sessions at the American Academy of Ophthalmology (AAO) 2021 annual meeting held in New Orleans. In addition, Ocuphire presented new data on improvement in intermediate vision and Snellen equivalent near vision at the Eyecelerator@AAO 2021 conference. Ocuphire was one of two companies presenting clinical data for presbyopia at this meeting.
In October 2021, the Company announced the publication of a review article titled "Inhibition of APE1/Ref-1 for Neovascular Eye Disease: From Biology to Therapy" in the Special Issue "Advances in Molecular Activity of Potential Drugs" of the International Journal of Molecular Sciences. The article underscores the role of the APE1/Ref-1 protein in pro-angiogenic pathways associated with neovascular eye disease including diabetic retinal diseases and age-related macular degeneration.
In October 2021, the Company announced the publication of a review article in Cells titled "Potential Therapeutic Candidates for Age-Related Macular Degeneration" noting the potential of APX3330 (referred to as "E3330"). The authors conclude that APE1/Ref-1 inhibitors such as APX3330 could inhibit the abnormal blood vessel formation seen in AMD by reducing retinal endothelial cell proliferation, migration, and tube formation.
In October 2021, Michael J. Allingham, MD, PhD presented at the 39th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) (Diabetic Retinopathy 1 Symposium) held in San Antonio, highlighting the favorable safety and tolerability data for APX3330 in over 300 healthy volunteers and cancer/hepatitis patients across 11 Phase 1 and Phase 2 studies. In addition, Mina Sooch, CEO, presented APX3330 history and the design of the ongoing Phase 2 trial in DR at the OIS Retina Innovation Summit@ASRS on October 7, 2021 in San Antonio, TX.
Fourth Quarter and Year Ended December 31, 2021 Financial Highlights

As of December 31, 2021, the Company had cash and cash equivalents of approximately $24.5 million. Based on current projections, management believes the current cash on hand will be sufficient to fund operations into the second quarter of 2023. Net cash used in operating activities for the quarter and year ended December 31, 2021 was $5.6 million and $19.4 million, respectively.

No collaboration revenue was recorded in the fourth quarter. Collaborative revenue was $0.6 million for the year ended December 31, 2021. Revenue was derived from the collaboration and license agreements with Processa and Biosense related to certain Rexhan products and technology transfers. There was no collaboration revenue recognized during the comparable prior year periods.

General and administrative expenses for the quarter and year ended December 31, 2021 were $1.4 million and $8.1 million, respectively, compared to $1.3 million and $2.8 million for the quarter and year ended December 31, 2020, respectively. The $5.3 million increase for the year over year periods was primarily attributable to administrative employee headcount, stock-based compensation, insurance, legal and settlement costs, costs associated with operating as a public company subsequent to the reverse merger, and professional services and other operating costs. General and administrative expenses included $0.3 million and $0.2 million in non-cash stock-based compensation expense during the quarters ended December 31, 2021 and 2020, respectively, and $1.1 million and $0.7 million in non-cash stock-based compensation expense during the years ended December 31, 2021 and 2020, respectively.

Research and development expenses for the quarter and year ended December 31, 2021 were $4.7 million and $15.2 million, respectively, compared to $4.3 million and $6.6 million for the quarter and year ended December 31, 2020, respectively. The $8.5 million increase for the year over year periods was primarily attributable to clinical trial expense, manufacturing activities to support clinical advancement of Nyxol and APX3330, consulting services as well as regulatory and other research and development efforts. Research and development expenses also included $0.2 million and $0.3 million in non-cash stock-based compensation expense during the quarters ended December 31, 2021 and 2020, respectively, and $0.8 million in non-cash stock-based compensation expense during each of the years ended December 31, 2021 and 2020.

The loss from operations for the quarter ended December 31, 2021 was $6.2 million, compared to $14.0 million for the quarter ended December 31, 2020. The loss from operations for the year ended December 31, 2021 was $22.7 million, compared to $20.0 million for the year ended December 31, 2020. Net loss for the quarter ended December 31, 2021 was $6.3 million, compared to $18.7 million for the quarter ended December 31, 2020. Net loss for the year ended December 31, 2021 was $56.7 million, compared to $24.6 million for the year ended December 31, 2020. Net loss per share for the quarter ended December 31, 2021 was $0.35, compared to $2.46 for the quarter ended December 31, 2020. Net loss per share for the year ended December 31, 2021 was $3.82, compared to $5.28 for the year ended December 31, 2020.

The fair value change in derivative and warrant liabilities was a non-cash expense of zero for the quarter ended December 31, 2021 compared to a non-cash expense of $1.6 million for the quarter ended December 31, 2020. The fair value change in derivative and warrant liabilities was a non-cash expense of $33.8 million for the year ended December 31, 2021 compared to a non-cash expense of $1.5 million for the year ended December 31, 2020.

For further details on Ocuphire’s financial results, refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 to be filed with the Securities and Exchange Commission.

On March 24, 2022 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease, reported that it will host an investor conference call on Thursday, March 31, 2022 at 2 p.m. Pacific Time to discuss its financial and operating results for the fourth quarter and full year 2021 as well as provide a business update (Press release, Adamis Pharmaceuticals, MAR 24, 2022, View Source [SID1234610921]). The company’s press release concerning its fourth quarter and 2021 financial results is expected to be available after 1 p.m. Pacific Time on March 31, 2022, and on its website. The company also expects to file its annual report on Form 10-K for the year ended December 31, 2021 on that date.

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Dennis J. Carlo, Ph.D., President and CEO of Adamis, will host the call along with other members of the management team. The call is open to the public and will provide an update on recent developments, events that have taken place during the year, and certain goals for future periods. Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

A live audio webcast of the conference call will also be available via this link, with a replay available shortly after the live event.

On March 24, 2022 Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading Pan-American (ex-US) specialty pharmaceutical company, reported financial results for its fourth quarter and year ended December 31, 2021 (Press release, Knight Therapeutics, MAR 24, 2022, View Source [SID1234610920]). All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

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2021 Highlights

Financials

Revenues were $243,478, an increase of $43,959 or 22% over prior year.
Gross margin of $115,412 or 47% compared to $81,690 or 41% in prior year.
Adjusted EBITDA1 was $38,005, an increase of $21,168 or 126% over prior year.
Net gain on financial assets measured at fair value through profit or loss of $18,944.
Net income was $15,675, compared to net income of $31,760 in prior year.
Cash inflow from operations was $44,618, compared to a cash outflow from operations of $12,205 in prior year.
Corporate Developments

Purchased 12,321,864 common shares through Knight’s Normal Course Issuer Bid ("NCIB") at an average price of $5.23 for an aggregate cash consideration of $64,415.
Performed leadership change with Samira Sakhia assuming role of CEO and Jonathan Goodman assuming role of Executive Chairman effective September 1, 2021.
Promoted Amal Khouri to Chief Business Officer.
Hired Jeff Martens as Global VP Commercial, Monica Percario as Global VP Scientific Affairs, Daniela Marino as Global VP Legal and Compliance and Susan Emblem as Global VP Human Resources.
Shareholders re-elected James C. Gale, Jonathan Ross Goodman, Samira Sakhia, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy and Janice Murray on the Board of Directors.
Products

Acquired, in May 2021, the exclusive rights to manufacture, market and sell Exelon (rivastigmine) in Canada and Latin America for an upfront and milestone payment of $217,331 [US$180,000].
Entered into exclusive supply and distribution agreement with Incyte for tafasitamab and pemigatinib for Latin America.
Launched Ibsrela (tenapanor) in Canada for the treatment of irritable bowel syndrome with constipation ("IBS-C").
Obtained regulatory approval for NERLYNX (neratinib) to treat subset of HER2-positive metastatic breast cancer patients in Canada.
Obtained regulatory approval for Halaven (eribulin mesylate) injection to treat locally advanced or metastatic breast cancer in Colombia and to treat advanced or metastatic liposarcoma.
Obtained regulatory approval for Lenvima (lenvatinib) to treat radioiodine refractory differentiated thyroid cancer ("RR-DTC") and unresectable hepatocellular carcinoma ("u-HCC") in Colombia.
Obtained regulatory approval of Rembre (dasatinib) to treat chronic myeloid leukemia in Colombia.
1 Adjusted EBITDA is a non-GAPP measure, refer to the definitions below for additional details.

Strategic Investments

Disposed of 315,600 common shares of Medexus for total proceeds of $2,624 realizing a gain of $1,639.
Received distributions of $30,931 from strategic fund investments, including $10,906 (US$8,774) final distribution from the liquidation of NEMO II fund, and realized a gain of $16,644.
Subsequent Events

Launched Lenvima and Rembre in Colombia in February 2022.
Launched Halaven in Colombia in March 2022.
Hired Leopoldo Bosano as VP Manufacturing and Operations in March 2022.
Purchased an additional 933,715 common shares through NCIB for an aggregate cash consideration of $4,997.
"I am excited to announce that 2021 was a record-setting year in Knight’s history, despite the ongoing challenges posed by the pandemic. During the year, we made significant strides towards completing the integration of the Grupo Biotoscana acquisition, all while strengthening the team and processes and driving strong performance.

As part of our integration activities, we completed the implementation of several key systems including, a global CRM, HR IS and a global pharmacovigilance system. In addition, we implemented ERP for 14 legal entities in 6 countries. We further strengthened Knight’s management team with the addition of a Global VP Commercial, a Global VP Scientific Affairs, a Global VP Legal and Compliance and a Global VP Human Resources and most recently added a VP Manufacturing and Operations, to continue delivering on growth and operational excellence. Our business development team closed the acquisition of Exelon and entered into an exclusive supply and distribution agreement with Incyte. Our regulatory team advanced our portfolio with the approval of Halaven, Lenvima and Rembre in Colombia as well as the approval of Nerlynx, while our commercial team continued to deliver on strong growth of our key brands.

It is thanks to the hard work of our employees that we achieved unprecedented results in 2021 and we are entering 2022 with a stronger platform that is well equipped to continue delivering on further growth and success." said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

1 A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss)
2 Percentage change is presented in absolute values
3 EBITDA and adjusted EBITDA are non-GAAP measures, refer to the definitions below for additional details
4 Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, amortization and impairment of intangible assets

1 A positive variance represents a positive impact to adjusted EBITDA and a negative variance represents a negative impact to adjusted EBITDA
2 Percentage change is presented in absolute values
3 Financial results at constant currency and excluding impact of IAS 29, EBITDA and adjusted EBITDA are non-GAAP measures, refer to the definitions below for additional details
4 Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, amortization and impairment of intangible assets

Revenues: For the quarter ended December 31, 2021 revenues increased by $3,082 or 6% compared to the same prior year period. On a constant currency basis, revenues increased by $2,951 or 6%. The growth in revenues on a constant currency basis is explained as following:

An increase in revenues of $7,095 driven by the acquisition of Exelon.
An increase in revenues of $1,612 or 13%, from $12,559 to $14,171, driven by the growth of our recently launched products, including Cresemba, Lenvima, Halaven, Nerlynx, Trelstar and certain BGx products.
The increase in revenues in Q4-21 vs. Q4-20 was offset by the buying pattern on certain of our infectious disease’s products. It is estimated that approximately $3,200 to $4,200 of products purchased in Q3-21 was not utilized in that quarter and resulted in lower sales in Q4-21.
For the year ended December 31, 2021 revenues increased by $43,959 or 22% compared to the same prior year period. On a constant currency basis, revenues increased by $48,832 or 26%. The growth in revenues on a constant currency basis is explained as following:

An estimated increase in revenues of approximately $13,500 to $16,300 driven by the increased demand of certain of our infectious diseases products to treat invasive fungal infections associated with COVID-19.
An increase in revenues of $21,187 driven by the acquisition of Exelon
An increase in revenues of $15,135 or 45%, from $33,897 to $49,032 driven by the growth of our recently launched products, including, Cresemba, Lenvima, Halaven, Nerlynx, Trelstar and certain BGx products.
Gross margin: For the quarter and year ended December 31, 2021, gross margin increased from 36% to 48% and from 41% to 47% respectively, compared to the same period in prior year due to a change in product mix, the acquisition of Exelon and related revenues recorded as a net profit transfer, lower inventory provision recorded offset by the re-negotiation of certain license agreements and the depreciation of the LATAM currencies. For the quarter and year ended December 31, 2021, the gross margin would have been 51%, an increase of 3%, from 48% and 50%, an increase of 3%, from 47%, after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Selling and marketing: For the quarter ended December 31, 2021, selling and marketing increased by $1,773 or 20% and on a constant currency basis by $1,155 or 13% as compared to the same prior year period, driven by an increase in certain variable costs such as logistics fees and annual incentive compensation as well as an increase in selling and marketing activities related to key promoted products and Exelon.

For the year ended December 31, 2021, selling and marketing expenses increased by $1,632 or 5% and on a constant currency basis by $1,801 or 5% as compared to the prior year. Excluding the non-recurring costs and the allowance for expected credit losses, selling and marketing expenses increased by $5,738 or 19%, from $30,052 to $35,790, due to an increase in certain variable costs such as logistics fees and annual incentive compensation as well as an increase in selling and marketing activities related to key promoted products and Exelon.

General and administrative: For the year ended December 31, 2021, general and administrative expenses decreased by $1,686 or 4% and on a constant currency basis by $1,136 or 3% as compared to the same period in prior year. Excluding the non-recurring costs and acquisition costs including the Unified Tender Offer, general and administrative expenses for the year ended December 31, 2021, increased by $2,953 or 10%, from $30,914 to $33,867, driven by an expense of $1,210 related to the extension of the expiry date of certain stock options and an increase in cost related to the annual incentive compensation.

Amortization of intangible assets: For the quarter and year ended December 31, 2021, amortization of intangible assets increased by $9,051, or 113% and $15,641, or 61% respectively, mainly explained by the amortization of $5,731 and $13,686 related to Exelon, the accelerated amortization of $5,435 related to the discontinuation of certain distribution agreements partially offset by the depreciation of LATAM currencies.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter and year ended December 31, 2021, interest income was $2,196 and $7,382, a decrease of 22% or $611 and 48% or $6,940 respectively, compared to the same period in prior year due to a lower average cash and marketable securities balances and loan balance.

Interest expense: For the quarter ended December 31, 2021 interest expense was $1,331, an increase of $1,003 or 306%, compared to the same period in prior year due to higher interest rates.

For the year ended December 31, 2021 interest expense was $3,618, an increase of $220 or 6%, compared to prior year due to a decrease in the average loan balance outstanding largely offset by higher interest rates.

Adjusted EBITDA: For the quarter ended December 31, 2021 adjusted EBITDA increased by $3,925 or 222% and on a constant currency basis by $4,342 or 321% compared to Q4-20. The growth in adjusted EBITDA is driven by an increase in gross margin of $6,929 on a constant currency basis offset by an increase in operating expenses adjusted for non-recurring expenses.

For the year ended December 31, 2021 adjusted EBITDA increased by $21,168 or 126% and on a constant currency basis by $24,169 or 175% compared to the same prior year period. The growth in adjusted EBITDA is driven by an increase in gross margin of $32,288 on a constant currency basis due to the increase in revenues offset by an increase in operating expenses adjusted for acquisition and transaction costs as well as non-recurring expenses.

Net loss or income: For the quarter ended December 31, 2021, net loss was $8,301 compared to net income of $8,233 for the same period last year. The variance mainly resulted from the above-mentioned items and (1) an income tax recovery of $6,123 in the fourth quarter of 2021 due to the recognition of certain deferred tax assets compared to an income expense of $2,618 in the prior year period as well as (2) a lower net gain on the revaluation of financial assets measured at fair value through profit or loss of $2,300 in the fourth quarter of 2021 versus a net gain of $25,418 in the prior year period mainly due to unrealized losses and gains on revaluation of the strategic fund investments.

For the year ended December 31, 2021, net income was $15,675 compared to net income of $31,760 in prior year. The variance mainly resulted from the above-mentioned items and (1) an income tax recovery of $8,985 in 2021 due to the recognition of certain deferred tax assets compared to a prior year income tax expense of $325 as well as (2) as well as a lower net gain on the revaluation of financial assets measured at fair value through profit or loss of $18,944 in 2021 versus a net gain of $48,060 in prior year mainly due to unrealized losses and gains on revaluation of the strategic fund investments.

Cash, cash equivalents and marketable securities: As at December 31, 2021, Knight had $149,502 in cash, cash equivalents and marketable securities, a decrease of $242,723 or 62% as compared to December 31, 2020. The variance is primarily due to cash outflows related to the acquisition of Exelon, the shares repurchased through NCIB and the repayments of bank loans offset by cash generated from operating activities and our strategic fund investments.

Financial assets: As at December 31, 2021, financial assets were at $192,443, a decrease of $1,512 or 1%, as compared to the prior year, mainly due to an increase of $19,329 due to mark-to-market adjustments offset by decrease of $14,502 due to net distributions in Knight’s fund investments, loan repayments of $2,684 and disposal of equity investments of $2,624 during the period. Given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets.

Bank Loans: As at December 31, 2021, bank loans were at $35,927, a decrease of $15,843 or 31% as compared to the prior period, mainly due to loan repayment of $20,599 and a $4,674 decrease due to depreciation of LATAM currencies, partially offset by proceeds from bank loans of $9,423.

Product Updates

On March 1, 2021 the Company launched Ibsrela for the treatment of IBS-C. The Company entered into an exclusive licensing agreement with Ardelyx to commercialize Ibsrela in Canada in March 2018. Ibsrela is a first-in-class small molecule treatment for IBS-C. Ardelyx received regulatory approval for Ibsrela from the US FDA in September 2019.

On May 26, 2021, the Company entered into an agreement with Novartis to acquire the exclusive rights to manufacture, market and sell Exelon, in Canada and Latin America as well as an exclusive license to use the intellectual property and the Exelon trademark, from Novartis within those territories. Exelon is a prescription product that was first approved in 1997 and is currently registered and sold in approximately 90 countries. Exelon is indicated for the symptomatic treatment of mild to moderately severe dementia in people with Alzheimer’s disease and Parkinson’s disease.

Knight has entered into a transition service agreement with Novartis until transfer of marketing authorization, on a country-by-country basis during which Knight will receive a net profit transfer. Knight will begin distributing Exelon upon transfer of marketing authorization, on a country-by-country basis. Knight has submitted the transfer of marketing authorizations for Brazil, Colombia, Mexico and Chile. Furthermore, Knight has received the regulatory notification that the marketing authorization for Exelon in Brazil will transfer to its affiliate in June 2022 and expects the marketing authorizations for other territories to start transferring in the second half of 2022.

On September 22, 2021, Knight entered into a definitive agreement with Incyte Biosciences International Sàrl, for the exclusive rights to distribute tafasitamab (sold as Monjuvi in the United States and Minjuvi in Europe) and pemigatinib (Pemazyre) in Latin America. Under the terms of the agreement Knight will be responsible for seeking the necessary regulatory approvals and distributing both products in Latin America. Knight expects to submit tafasitamab in key LATAM countries in 2022 and pemigatinib in 2023.

Knight obtained regulatory approval for Rembre in Colombia, indicated for treatment of chronic myeloid leukemia with positive Philadelphia chromosome (Ph+). The product was launched in Colombia in February 2022.

Knight obtained INVIMA approval for Lenvima in Colombia, the orally available multiple receptor tyrosine kinase inhibitor developed by Eisai, for the treatment of RR-DTC and u-HCC. Knight launched Lenvima in Colombia in February 2022.

Knight obtained INVIMA approval for Halaven injection in Colombia, indicated for the treatment of adult patients with locally advanced or metastatic breast cancer which has continued to spread after at least two previous treatment for advanced cancer. Previous treatment should have included anthracyclines and a taxane in either the adjuvant or metastatic setting, unless these treatments were not suitable. Halaven is also used to treat patients with advanced or metastatic liposarcoma that cannot be surgically removed and who have already been treated with an anthracycline, unless deemed unsuitable. Knight launched Halaven in Colombia in March 2022.

NCIB

On July 12, 2021, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch a NCIB ("2021 NCIB"). Under the terms of the 2021 NCIB, Knight may purchase for cancellation up to 10,267,956 common shares of the Company which represented 10% of its public float as at December 31, 2021. The 2021 NCIB commenced on July 14, 2021 and will end on the earlier of July 13, 2022 or when the Company completes its maximum purchases under the NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the NCIB. Under Knight’s automatic share purchase plan, the broker may purchase common shares which would ordinarily not be permitted due to regulatory restrictions or self-imposed blackout periods. For the year ended December 31, 2021, the Company purchased 12,321,864 (2020: 5,748,716) common shares at an average price of $5.23 (2020: $6.40) for an aggregate cash consideration of $64,415 (2020: $36,787). Subsequent to 2021, the Company purchased an additional 933,715 common shares at an average purchase price of $5.35 for an aggregate cash consideration of $4,997.

Financial Outlook

Knight provides guidance on revenues1 on a non-GAAP basis. This is due to both the difficulty in predicting Argentinian inflation rates and its IAS 29 impact.

For fiscal 2022, Knight expects to generate $260 to $265 million in revenue. The guidance is based on a number of assumptions, including but not limited to the following:

no revenues for business development transactions not completed as of December 31, 2021
discontinuation of certain distribution agreements
Exelon marketing authorization transfer to Knight in June 2022 in Brazil
no interruptions in supply whether due to global supply chain disruptions or general manufacturing issues
no new generic entrants on our key pharmaceutical brands
no unforeseen changes to government mandated pricing regulations
successful commercial execution on product listing arrangements with HMOs, insurers, key accounts, and public payers
successful execution and uptake of newly launched products
no significant restrictions or economic shut down due to the COVID-19 pandemic
foreign currency exchange rates remaining within forecasted ranges
Should any of the assumptions differ, the financial outlook and the actual results may vary materially. Refer to the risks and assumptions referred to in the Forward-Looking Statements section of this news release for further details.

1 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to the definitions below for additional details

Conference Call Notice

Knight will host a conference call and audio webcast to discuss its fourth quarter and year-end results today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

On March 24, 2022 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will release full year 2021 results and corporate update on Thursday, March 31, 2022 (Press release, Affimed, MAR 24, 2022, View Source [SID1234610919]). The Company will host a conference call at 8:30 a.m. Eastern Daylight Time.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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 conference call will be available via phone and webcast. To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference conference ID 6590614 approximately 15 minutes prior to the call. To access the live audio webcast of the conference call please visit the "Investors" section of the company’s website at View Source A replay of the call will be archived on Affimed’s website for 30 days after the call.

On March 24, 2022 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported the publication of preclinical data from MP0317 in Cancer Immunology Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Molecular Partners, MAR 24, 2022, View Source [SID1234610918]). MP0317 is the Company’s second immuno-oncology program to enter clinical studies and is designed to target both FAP (fibroblast activation protein), a protein found in high density around tumors, and the immunostimulatory protein CD40, to enable tumor-localized immune activation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The CD40 receptor, which is expressed on dendritic cells, B cells and macrophages, is an attractive target for cancer immunotherapy. However, administration of CD40-targeting monoclonal antibodies has challenges with achieving a meaningful clinical response. Low concentrations result in minimal efficacy, but higher concentrations rapidly lead to systemic toxicity, limiting the therapeutic window achievable with systemic CD40 activation. The DARPin therapeutic candidate MP0317 is designed to specifically induce CD40-mediated immune activation only in the FAP-rich local tumor environment, preventing systemic immune activation.

The published study confirms that MP0317 is inducing FAP-dependent CD40-mediated B and myeloid cell activation, thus supporting the candidate intended mechanism of action of tumor-localized immune activation without the systemic toxicity observed with other CD40-targeting agents. This study suggests that MP0317, as a DARPin therapeutic candidate, has the potential for a broader therapeutic window and thus improved clinical activity compared to CD40 agonist antibodies. The publication can be found in this link.

MP0317 is currently being tested in a Phase 1 clinical trial sponsored by the Company. The open-label dose escalation study is designed to assess the safety and tolerability as well as pharmacokinetics and pharmacodynamics of MP0317 as a monotherapy in patients with solid tumors known to express FAP. In addition to evaluating monotherapy dynamics, the study will gather biomarker data to support the establishment of combination studies of MP0317 with other therapies in specific indications.

Initial data from the ongoing Phase 1 clinical trial are expected in the second half of 2022.