On May 16, 2022 Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") reported they have reached an agreement with the European Commission (EC) to amend their originally agreed contractual delivery schedules for the Pfizer-BioNTech COVID-19 Vaccine (Press release, BioNTech, MAY 16, 2022, View Source [SID1234614657]). This amendment rephases planned deliveries to help support the European Commission and Member States’ ongoing immunization programs, and is aligned to the companies’ commitment to working collaboratively to identify pragmatic solutions to address the evolving pandemic needs. Doses scheduled for delivery in June through August 2022 will now be delivered in September through fourth quarter 2022. The companies’ full-year 2022 revenue guidance and the full-year commitment of doses to be delivered to EC Member States in 2022 remain unchanged.

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Pfizer and BioNTech continue to evaluate potential adapted vaccines, including variant-based vaccines.

U.S. Indication & Authorized Use

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older.

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:

Primary Series

a 2-dose primary series to individuals 5 years of age and older
a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise
Booster Series

a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA)
a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine
COMIRNATYINDICATION

COMIRNATY (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

COMIRNATY is administered as a 2-dose primary series
COMIRNATY AUTHORIZED USES

COMIRNATY (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:

Primary Series

a 2-dose primary series to individuals 12 through 15 years of age
a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
Booster Dose

a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY
a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine

Emergency Use Authorization

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in either individuals 12 years of age and older, or in individuals 5 through 11 years of age, as appropriate. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

INTERCHANGEABILITY

FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA-authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

The formulation of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age differs from the formulations authorized for individuals 12 years of age and older and should therefore not be used interchangeably. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age should not be used interchangeably with COMIRNATY (COVID-19 Vaccine, mRNA).

IMPORTANT SAFETY INFORMATION

Tell your vaccination provider about all of your medical conditions, including if you:

have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects the immune system
are pregnant, plan to become pregnant, or are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) may not protect all vaccine recipients
You should not receive Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) if you have had a severe allergic reaction to any of its ingredients or had a severe allergic reaction to a previous dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY
There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) could cause a severe allergic A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital
Seek medical attention right away if you have any of the following symptoms:

difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low
Seek medical attention right away if you have any of the following symptoms after receiving the vaccine:

chest pain
shortness of breath
feelings of having a fast-beating, fluttering, or pounding heart
Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA). Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask you to sit or lie down for 15 minutes after receiving the vaccine
Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA)
Additional side effects include injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; and fainting in association with injection of the vaccine
These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

You should always ask your healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report online to www.vaers.hhs.gov/reportevent.html. You can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

On May 16, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company reported financial results for the first quarter ended March 31, 2022 (Press release, Alaunos Therapeutics, MAY 16, 2022, View Source [SID1234614656]).

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"Dosing of the first patient in our TCR-T Library Phase 1/2 trial speaks to the dedication of our entire team and reaffirms our commitment to execution. We are working to continue enrolling patients in the trial and expect to provide an initial look at data later this year," commented Kevin S. Boyle, Sr., Chief Executive Officer. "We are honored to have two posters supporting our TCR-T platform targeting solid tumors at the upcoming ASGCT (Free ASGCT Whitepaper) and ASCO (Free ASCO Whitepaper) conferences. We believe we have positioned Alaunos for success and look forward to continued progress."

Recent Developments and Upcoming Milestones

TCR-T Library Trial: In May 2022, the Company announced that it had dosed the first patient with non-viral TCR-T cells in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53, and EGFR mutations across six solid tumor indications. This is a major milestone for Alaunos as it also represents the first clinical product manufactured and administered to a patient using the Company’s in house cGMP manufacturing facility.

The study is being conducted at The University of Texas MD Anderson Cancer Center and is an open label, dose escalation study, with patients to be treated in one of three dosing cohorts: 5×109, 4×1010, or 1×1011 TCR-T cells. The trial is enrolling patients with non-small cell lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers that have a matching human leukocyte antigen (HLA) and hotspot mutation pairing in Alaunos’ TCR-T library. The main study objectives are to define the maximum tolerated dose, recommended phase 2 dose and safety profile. The Company will present a trial in progress poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and expects to report initial data in the second half of 2022. Additional information about the study is available at www.clinicaltrials.gov using the identifier: NCT05194735.

Presenting preclinical data supporting membrane bound IL-15 (mbIL-15) at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting: Today, the Company will present preclinical data for its mbIL-15 program at the ASGCT (Free ASGCT Whitepaper) 25th Annual Meeting. The poster titled, "Stem-cell memory TCR-T cells targeting hotspot EGFR, KRAS and p53 neoantigens generated through co-expression of membrane-bound Interleukin-15" highlights the potential of mbIL-15 to establish long-lived tumor-specific TCR-T cells. The Company intends to file an IND application for this program in the second half of 2023.

First Quarter Ended March 31, 2022 Financial Results

Research and Development Expenses: Research and development expenses were $5.6 million for the first quarter of 2022, compared to $13.3 million for the first quarter of 2021, a decrease of approximately 58%. The decrease was primarily due to lower program-related costs as a result of the winding down of our IL-12 and CAR-T programs and lower employee related expenses due to our reduced headcount following our strategic restructuring event in the third quarter of 2021.

General and Administrative Expenses: General and administrative expenses were $3.5 million for the first quarter of 2022, compared to $8.2 million for the first quarter of 2021, a decrease of approximately 57%. The decrease was primarily due to lower employee related expenses due to our reduced headcount following our strategic restructuring event in the third quarter of 2021 and a decrease in consulting and professional services expenses.

Net Loss: Net loss was $9.8 million, or $(0.05) per share, for the first quarter of 2022, compared to a net loss of $21.6 million, or $(0.10) per share, for the same period in 2021.

Cash and Cash Equivalents: As of March 31, 2022, Alaunos had approximately $68.3 million in cash and cash equivalents. The Company anticipates its cash runway will be sufficient to fund operations into the second quarter of 2023. Operating cash burn for the first quarter of 2022 was $7.8 million compared to $15.3 million in the first quarter of 2021, a decrease of $7.5 million or 49%.

Conference Call and Webcast

The conference call can be accessed by dialing 844-309-0618 (United States) or 661-378-9465 (International) with the conference code 2495623. A live webcast may be accessed using the link here, or by visiting the "Investors" section of the Alaunos website at www.alaunos.com. After the live webcast, the event will be archived on the Company’s website for approximately 30 days after the call.

On May 16, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the first quarter ended March 31, 2022 and provided recent corporate updates (Press release, Galera Therapeutics, MAY 16, 2022, View Source [SID1234614655]).

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"We are excited to announce our plan to submit an NDA for avasopasem by year end following discussions with the FDA," said Mel Sorensen, M.D., Galera’s President and CEO. "Based on the positive data readout from our Phase 3 ROMAN trial, Galera continues to execute on its development strategy to advance its lead program, avasopasem, toward potential commercialization. To that end, we are delighted to attend the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting where our ROMAN data will be highlighted in an oral presentation. In addition, we recently announced positive topline data from our Phase 2a AESOP study of avasopasem for chemoradiotherapy-induced esophagitis in patients with lung cancer. We are encouraged by these results, which further demonstrate avasopasem’s ability to reduce radiation toxicity in high-risk patient populations."

Recent Corporate Updates

Radiotherapy-Induced Toxicity Programs:

Severe Oral Mucositis (SOM)

The Company announced plans to submit a New Drug Application (NDA) for avasopasem, its lead product candidate, for the treatment of radiotherapy-induced SOM to the U.S. Food and Drug Administration (FDA) by the end of 2022.
An abstract on the Phase 3 ROMAN data of avasopasem for SOM was accepted for an oral presentation on June 3rd at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Esophagitis

The Company reported positive topline data from the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of severe acute radiation-induced esophagitis in patients with lung cancer receiving concurrent chemoradiotherapy. Overall, avasopasem was well tolerated and the incidence of Grade 3 esophagitis was substantially reduced in comparison to literature. No patients experienced Grade 4 or 5 esophagitis at any point during the trial.
Anti-Cancer Programs:

Locally Advanced Pancreatic Cancer (LAPC)

Enrollment is ongoing in the Phase 2b, 160-patient randomized, multicenter, placebo-controlled GRECO-2 trial of rucosopasem, Galera’s second dismutase mimetic product candidate, in combination with stereotactic body radiation therapy (SBRT) in patients with LAPC. The primary endpoint of the trial is overall survival.
A Trials in Progress abstract on GRECO-2 was accepted for presentation at the upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting.
Non-Small Cell Lung Cancer (NSCLC)

Enrollment is ongoing in the Phase 1/2 GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. The Company expects to report initial data from this trial in the first half of 2022.
First Quarter 2022 Financial Highlights

Research and development expenses were $8.1 million in the first quarter of 2022, compared to $12.4 million for the same period in 2021. The decrease was primarily attributable to a decrease in avasopasem development costs, partially offset by an increase in rucosopasem development costs.
General and administrative expenses were $5.0 million in the first quarter of 2022, consistent with the first quarter of 2021.
Galera reported a net loss of $(15.4) million, or $(0.58) per share, for the first quarter of 2022, compared to a net loss of $(18.7) million, or $(0.75) per share, for the same period in 2021.
As of March 31, 2022, Galera had cash, cash equivalents and short-term investments of $60.9 million. Galera expects that its existing cash, cash equivalents and short-term investments will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2023.

On May 16, 2022 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three months ended March 31, 2022 (Press release, Nuvo Pharmaceuticals, MAY 16, 2022, View Source [SID1234614654]). For further details on the results, please refer to Miravo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements for the three months ended March 31, 2022, which are available on the Company’s website (www.miravohealthcare.com). All figures are in Canadian dollars, unless otherwise noted.

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Key Developments

Three months ended March 31, 2022 include the following:

Total revenue was $15.6 million, an increase of 8% compared to $14.4 million for the three months ended March 31, 2021. Adjusted total revenue(1) was $15.7 million, an increase of 8% compared to $14.5 million for the three months ended March 31, 2021.
Net income was $2.0 million compared to net loss of $18.0 million for the three months ended March 31, 2021. Adjusted EBITDA(1) was $3.1 million, a decrease of 28% compared to $4.4 million for the three months ended March 31, 2021.
Revenue related to the Blexten franchise, Cambia and Suvexx was $8.1 million, an increase of 38% compared to revenue of $5.9 million for the three months ended March 31, 2021. Total Canadian prescriptions of Blexten, Cambia and Suvexx increased by 21%, 1% and 120%, respectively compared to the three months ended March 31, 2021.
The Company repaid $3.5 million (US$2.8 million) of the Amortization Loan to Deerfield Management Company, L.P. (Deerfield).
As at March 31, 2022, cash and cash equivalents were $26.5 million.
(1)

Non-IFRS financial measure. These measures are not recognized under IFRS and do not have standardized meanings prescribed by IFRS. See the Non-IFRS Measures section for definitions, reconciliations and the basis of presentation of the Company’s non-IFRS measures.

Business Update

In May 2022, Miravo become aware that the United States’ Food & Drug Administration (FDA) approved Apotex Inc.’s abbreviated new drug application for a generic version of Pennsaid 2% on May 6, 2022. Miravo’s partner in the United States owns the Pennsaid 2% intellectual property rights in the United States and has carriage and full decision-making authority with respect to any litigation related to this matter. Miravo is the exclusive manufacturer of Pennsaid 2% for its U.S. partner. The entry of a generic version of Pennsaid 2% may have a material and adverse impact on Miravo’s Production and Service Business segment.
In May 2022, Miravo filed U.S., Canadian, European and PCT patent applications for a reformulated and improved version of Resultz. This new formulation maintains the original 5-minute treatment claim, but is now enhanced with a 100% effectiveness claim for killing nits (the lice eggs) in addition to head lice. The Company believes this enhanced efficacy against nits adds value to existing Resultz partners, as well as other companies active in the head lice category globally who may be interested in licensing the technology. The Company will begin the partnering process for this new intellectual property during Q2 2022. Additional basic development work is anticipated to be conducted to support the new product.
In February 2022, the United States District Court for the District of New Jersey granted a motion for summary judgment filed by Dr. Reddy’s Laboratories Inc. (Dr. Reddy’s). As a result, the asserted claims of Nuvo Pharmaceuticals (Ireland) DAC’s (Miravo Ireland) U.S. Patent Nos. 8,858,996 (the ‘996 Patent) and 9,161,920 (the ‘920 Patent) related to Vimovo in the U.S. were found to be invalid. Both the ‘996 and the ‘920 patents were to expire May 31, 2022. Miravo Ireland and its partner have not appealed this decision.
In February 2022, Blexten for pediatric use in patients 4 years of age and older* was commercially launched in Canada. The pediatric use includes two new dosage formats; a 2.5mg/mL oral solution and a 10mg orodispersible tablet (quick melt) for the treatment of the symptoms of seasonal allergic rhinitis and chronic spontaneous urticaria (such as itchiness and hives). The pediatric formats are available to patients with a prescription from their healthcare provider.
"Our Commercial Business segment continues to perform well with Q1 year-over-year adjusted total revenue growth driven by increased Blexten, Suvexx and Cambia prescriptions. Our final $375,000 sales-based milestone for the Blexten business was triggered during the quarter. This payment recognized the achievement of $60 million in cumulative net sales of Blexten in Canada – a milestone we are very proud of. As we look to the remainder of 2022, we anticipate continued year-over-year quarterly growth in the Commercial Business segment consistent with the seasonality this business has experienced in the past," said Jesse Ledger, Miravo’s President & CEO. "The financial impact of generic competition on our U.S. Vimovo royalty stream is now fully realized resulting in revenue stabilization in our Licensing and Royalty Business segment moving forward. Certain shipments to international customers were produced, but due to COVID-related delays, were not delivered in time to be recognized as revenue during Q1 in our Production and Service Business segment. While our business continues to be impacted by the COVID-19 pandemic, we are encouraged to see increasing numbers of patient/physician visits and look forward to a return to pre-COVID activity levels in the coming quarters."

First Quarter 2022 Financial Results

Adjusted total revenue was $15.7 million for the three months ended March 31, 2022 compared to $14.5 million for the three months ended March 31, 2021. The $1.2 million increase in adjusted total revenue in the current quarter was primarily attributable to an increase of $2.4 million of revenue in the Commercial Business segment, offset by a decrease of $0.9 million of revenue in the Production and Service Business segment combined with a decrease of $0.3 million in the Licensing and Royalty Business segment.

Revenue attributable to the Commercial Business segment increased during the three months ended March 31, 2022 due to a $2.2 million increase in sales of the Company’s promoted products (Blexten, Cambia, Suvexx and NeoVisc) and a $0.2 million increase in sales of the Company’s mature products.

* Blexten (bilastine) is indicated for the symptomatic relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and chronic spontaneous urticaria (e.g. pruritus and hives) in patients 4 years of age and older with a body weight of at least 16 kg.

The Production and Service Business segment revenue decreased during the three months ended March 31, 2022, primarily due to a decrease in Pennsaid 2% product sales, slightly offset by an increase in sales of Pennsaid and Resultz.

The decrease in revenue attributable to the License and Royalty business segment during the three months ended March 31, 2022 was primarily attributable to a $0.5 million reduction in U.S. Vimovo royalty revenue due to a step-down in royalty to 5% of net sales compared to 10% of net sales in the comparative quarter, as well as a $0.1 million reduction in the Company’s Vimovo ex-U.S. royalties. In the current quarter, the decline in license revenue was offset by a $0.2 million milestone payment related to a sublicensee agreement for Vimovo ex-U.S.

Adjusted EBITDA was $3.1 million for the three months ended March 31, 2022 compared to $4.4 million for the three months ended March 31, 2021. During the three months ended March 31, 2022, a $0.9 million increase in gross profit from the Commercial Business segment was more than offset by a $0.3 million decrease in the contribution from the License and Royalty Business segment, a $0.7 million decrease in gross profit contribution from the Production and Service Business segment and a $0.9 million increase in G&A expenses.

Non-IFRS Measures

The Company discloses non-IFRS financial measures (adjusted total revenue, adjusted EBITDA, and cash value of loans) and non-IFRS ratios (adjusted EBITDA per share and net debt leverage ratio) that are not recognized under and do not have standardized meanings prescribed by IFRS. Accordingly, such measures are not necessarily comparable and may not have been calculated in the same way as similarly named financial measures presented by other companies. These measures should be considered as supplemental in nature and not as a substitute for related financial information prepared in accordance with IFRS. The Company believes that shareholders, investment analysts and other readers find such measures and ratios helpful in understanding and assessing the Company’s financial performance. We utilize these measures in managing our business, including as means of performance measurement, cash management, debt compliance and assessing leverage and borrowing capacity. Because non-IFRS financial measures and non-IFRS ratios do not have standardized meanings prescribed under IFRS, securities regulations require that such measures be clearly defined, identified, and for non-IFRS financial measures, reconciled to their nearest IFRS measure. The applicable definition, calculation and reconciliation of each such measure used in this press release is provided below.

Adjusted Total Revenue

The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure to determine the Company’s ability to generate cash from its customer contracts used to fund its operations.

The following is a summary of how adjusted total revenue is calculated, reconciled to the nearest IFRS measure:

EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as EBITDA, plus amounts billed to customers for existing contract assets, inventory step-up expenses, stock-based compensation expense, loss on fair value of derivative liabilities, loss on fair value of contingent and variable consideration, impairment loss, foreign currency loss, other losses less revenue recognized upon recognition of a contract asset, stock-based compensation recovery, gain on fair value of derivative liabilities, gain on fair value of contingent and variable consideration, impairment recovery, foreign currency gain and other income. Management believes adjusted EBITDA is a useful supplemental measure to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

The following is a summary of how EBITDA and adjusted EBITDA are calculated, reconciled to the nearest IFRS measure:

(1) Income tax expense for the three months ended March 31, 2022 includes $0.3 million for deferred income tax due to the utilization of loss carryforwards that were previously recognized [$0.3 million for the three months ended March 31, 2021].

(2) The Company’s derivative liabilities are measured at fair value through profit or loss at each reporting date. As a result of the decrease in the share price in the current quarter and a decrease in the volatility of the Company’s shares, amongst other inputs, the value of the Company’s derivative liabilities decreased and the Company recognized a net non-cash gain of $3.3 million on the change in fair value of derivative liabilities for the three months ended March 31, 2022.

Management to Host Conference Call/Webcast

Miravo’s 2022 Annual Meeting of Shareholders (Meeting) will be held as an online meeting only. The Meeting will take place on Monday, May 16, 2022 (today) at 9:00 a.m. Registered shareholders can attend the Meeting online, vote shares electronically if they have not voted by proxy in advance of the Meeting in accordance with the proxy instructions, and submit questions during the Meeting. You will need to have your 16-digit Control Number (the Control Number) to participate in the Meeting. If you are a shareholder and do not have a Control Number or if you are not a Miravo shareholder, you can attend the Meeting as a guest, but you will not be able to vote at the Meeting.

The link to participate in the Meeting is: www.virtualshareholdermeeting.com/mrv2022. If you encounter any difficulties accessing the virtual meeting during the check-in or meeting time, please call the technical support number that will be posted on the Virtual Shareholder Meeting log in page.

On May 16, 2022 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported first quarter 2022 financial results and business highlights (Press release, Biomea Fusion, MAY 16, 2022, View Source [SID1234614653]).

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"We had a very exciting start to the year as we initiated our first Phase I study of BMF-219, COVALENT-101, in AML and ALL patients. We have now expanded enrollment to include also DLBCL and MM patients. Targeting menin with our covalent inhibitor is an innovative approach with potential safety, tolerability, efficacy, and durability advantages. Our COVALENT-101 investigators are enthusiastic to use BMF-219 for many of their patients who currently have relapsed from or not responded to traditional approaches," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board.

Mr. Butler continued, "We believe covalent inhibitors afford the optimal profile for a therapeutic. The aim is to maximize depth and durability of response, to support improved survival, while minimizing exposure, which is the source for unwanted toxicity. We have now provided preclinical evidence highlighting BMF-219’s profound anti-tumor effects in MYC-driven cancers and pan-KRAS mutant solid tumors. By indirectly targeting MYC and KRAS via the scaffold protein menin, our preclinical data demonstrates that BMF-219 can affect these oncoproteins in a very meaningful way. We are managing our expenses and will continue to execute on the clinical development of this first-in-human and first-in-class covalent menin inhibitor not only in the various tumor types, but also in type 2 diabetic patients."

Clinical and Regulatory Highlights

Enrolled first patient in first-in-human Phase I clinical trial evaluating BMF-219 in patients with relapsed or refractory acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations.
Presented preclinical data at AACR (Free AACR Whitepaper) 2022 highlighting impact of BMF-219 on MYC- and KRAS-driven solid tumors. Building on prior data, BMF-219 exhibited robust anti-tumor effect in cell lines and PDX models in DLBCL and MM cell lines.
Announced upcoming presentation of preclinical BMF-219 data from multiple in vivo models of diabetes at ADA Scientific Sessions 2022.
Announced upcoming presentation of preclinical BMF-219 data from multiple ex vivo models of CLL at ASCO (Free ASCO Whitepaper) 2022.
Corporate Highlights

Appointed Steve Morris, M.D. as Chief Medical Officer. Dr. Morris led a basic and translational research laboratory at St. Jude Children’s Research Hospital, where he served for 25 years. Among his lab’s pioneering work at St. Jude was the discovery and characterization of anaplastic lymphoma kinase, or ALK.
First Quarter 2022 Financial Results

Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $16.4 million for quarter ended March 31, 2022, compared to a net loss of $5.9 million for the same period in 2021.
R&D Expenses: Research and development expenses were $11.4 million for the quarter ended March 31, 2022, compared to $3.8 million for the same period in 2021. The increase of $7.6 million was primarily due to an increase in personnel-related expenses, as well as an increase in preclinical and clinical development costs, including manufacturing and external consulting, related to the Company’s lead product candidate, BMF-219.
G&A Expenses: General and administrative expenses were $5.1 million for the quarter ended March 31, 2022, compared to $2.1 million for the same period in 2021. The increase of $3.0 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company.
Cash, Cash Equivalents, Restricted Cash, and Investments: As of March 31, 2022, the Company had cash, cash equivalents, restricted cash, and investments of $165.6 million, compared to $175.7 million as of December 31, 2021.