On March 21, 2022 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported financial results for 2021 and provided a business update (Press release, Diffusion Pharmaceuticals, MAR 21, 2022, View Source [SID1234610467]).

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Corporate Strategy and Events

Business and financial highlights during 2021 and 2022 year-to-date include:

Declared Lead Development Program: The Company announced its intent to develop its novel, oxygen enhancing therapeutic, Trans Sodium Crocetinate ("TSC"), as an adjunct to standard of care therapy for hypoxic solid tumors in November 2021 ("Hypoxic Solid Tumor Program").

Strengthened Balance Sheet: In February 2021, the Company raised approximately $34.5 million in gross proceeds through an up-sized, follow-on public offering of its common stock with proceeds to be used to fund research and development efforts for the TSC oxygenation trials ("Oxygenation Trials") and corporate expenses. As of December 31, 2021, the Company reported a total of $37.3 million in cash and cash equivalents. As of March 18, 2022, the Company expects cash resources to fund operations through 2023.

Board Updates: Jane Hollingsworth appointed as new Board Chair in June 2021. Diana Lanchoney, M.D., and Eric Francois also elected to the Company’s board of directors in June 2021.

"We are pleased with the progress we achieved in 2021. We executed our corporate, clinical, and regulatory strategies, accelerating development of our lead product candidate, TSC. The capital we raised in the first half of 2021 allowed us to design and execute critical clinical trials to assess TSC’s therapeutic potential in treating hypoxia-related conditions using three unique short-term experimental clinical models of oxygenation," said Robert Cobuzzi, Jr., Ph.D., President and Chief Executive Officer of Diffusion.

Dr. Cobuzzi continued, "We believe the hard work demonstrated by our team in 2021 has laid a solid foundation for Diffusion’s success in 2022. The initiation of our Altitude and ILD-DLCO trials in the last quarter of 2021 represented a significant inflection point on the route to achieving the goal of demonstrating TSC’s potential to enhance the body’s ability to deliver oxygen to areas where it is needed most and potentially provide a novel treatment option for a variety of conditions complicated by hypoxia. Moreover, in late 2021 we announced our intent to design and execute a clinical program to support the use of TSC as an adjunct treatment of hypoxic solid tumors as the next step in our efforts to realize TSC’s potential. We believe targeting hypoxic solid tumors is appropriate for TSC given the significant unmet medical need, the compelling preclinical and clinical data accumulated to date, and the current, intravenous formulation of TSC. The team has been working closely with our advisors to design a Phase 2 study that we believe, if successful, will help patients and enhance shareholder value."

Clinical Trial Execution & Strategy

TCOM Trial: In March 2021, the Company completed enrollment and dosing of all participants in its Phase 1 trial of TSC utilizing a transcutaneous oxygen monitoring ("TCOM") device to evaluate the pharmacodynamic effects of TSC on peripheral tissue oxygenation in healthy, normal volunteers. As reported in June 2021, the topline results of the study showed TSC was safe and tolerable at all doses tested with no serious adverse events or dose-limiting toxicities. Furthermore, the Company announced that a positive trend in peripheral tissue oxygenation was observed among participants treated with TSC when compared to placebo-treated participants. This trend persisted through the one-hour, post-dosing measurement period. The Company believes the data from the TCOM Trial validate the thesis that TSC enhances oxygenation without causing hyperoxygenation. The data from the TCOM Trial have guided the design of the two additional Oxygenation Trials, as well as the design of the Hypoxic Solid Tumor Program.

Altitude Trial: In November 2021, Diffusion announced the dosing of the first participants in the Altitude Trial which was designed to evaluate the effects of TSC in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions, or "simulated altitude." Due to enrollment delays experienced during early 2022 related to the omicron variant wave of the COVID-19 pandemic, the Company now anticipates completing dosing in the second quarter of 2022 and topline results are expected to be reported within one to two months of study completion.

ILD-DLCO Trial: Subsequent to receiving Investigational New Drug application clearance from the U.S. Food and Drug Administration ("FDA") in the third quarter of 2021, the Company announced the dosing of the first patient in the Phase 2 ILD-DLCO Trial in December 2021. The ILD-DLCO Trial was designed to evaluate the effects of TSC on carbon monoxide uptake through the lungs ("DLCO") and into the bloodstream of interstitial lung disease ("ILD") patients. DLCO measurement is used in the study as a surrogate measure of oxygen transfer efficiency, or uptake, from the alveoli of the lungs through the plasma, and onto hemoglobin within red blood cells. The Company intends to evaluate the effect of TSC on lung function as measured by DLCO, as well as distance covered in a standard six-minute walk test. Due to enrollment delays experienced during early 2022 related to the omicron variant wave of the COVID-19 pandemic, the effect of the omicron variant on patients with pulmonary diseases such as ILD, and staffing issues at the facilities where the ILD-DLCO Trial is being conducted, the Company now anticipates dosing to be completed by the middle of 2022, with topline results reported within two months of study completion.

Hypoxic Solid Tumor Treatment: In November 2021, based on the available preclinical and clinical data and the significant unmet medical need, including the TCOM and COVID-19 Trial results, the Company announced its intent to focus its near-term efforts on evaluating TSC as an adjunct to standard of care in the treatment of hypoxic solid tumors as a first indication. Solid tumors, which comprise approximately 90% of all adult cancers, are often affected by hypoxia, leading to treatment resistance, metastasis, and worse prognoses. Following, among other things, analyses and discussions with the Company’s oncology-focused SAB members and other external advisors over the last several months, Diffusion believes they have the necessary data to support the design and initiation of an appropriate Phase 2 trial as the first study in the Hypoxic Solid Tumor Program. The Company intends to file the study protocol with the FDA and expects to commence the trial in the second half of 2022, subject to FDA feedback and the availability of clinical drug supply.

2021 Financial Results

Diffusion had cash and cash equivalents of $37.3 million as of December 31, 2021, compared with $18.5 million as of December 31, 2020. Net cash used in operating activities during 2021 was $14.5 million, compared with $13.6 million used during 2020.

Research and development expenses were $8.5 million for 2021, compared with $9.4 million for 2020. The decrease was primarily attributable to lower project spending due to the completion and/or wind-down of the Company’s clinical studies evaluating TSC in COVID-19, glioblastoma multiforme brain cancer, and stroke.

General and administrative expenses were $7.4 million for 2021, compared with $6.4 million for 2020. The increase was primarily driven by increased headcount resulting in higher compensation expense and other costs associated with the hiring of new employees, as well as an increase in expense related to consulting services.

In 2021, the Company also recognized a non-recurring $8.6 million non-cash impairment charge related to the write down of its DFN-529 IPR&D asset.

On March 21, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, reported the implementation of a liquidity agreement with Kepler Cheuvreux to enhance the liquidity of the Maat Pharma shares admitted to trading on Euronext Paris (Press release, MaaT Pharma, MAR 21, 2022, View Source [SID1234610466]).

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The implementation of this liquidity agreement, pursuant to the authorization granted by the resolution of the General Meeting, will be carried out in accordance with the legal framework in force, and more particularly to the provisions of Regulation (EU) No. 596/2014 of the European Parliament and of the Council of April 16, 2014 on market abuse (MAR), Commission Delegated Regulation (EU) 2016/908 of February 26, 2016 supplementing Regulation (EU) No. 596/2014 of the European Parliament and of the Council with regulatory technical standards on the criteria, procedure and requirements for the establishment of an admitted market practice and the requirements for maintaining, discontinuing or modifying its conditions of admission, Articles L. 225-209 et seq. of the French Commercial Code and AMF decision no. 2021-01 of June 22, 2021, applicable as of July 1, 2021.

The following resources will be allocated to the liquidity account:

200,000 euros
The execution of the liquidity contract could be suspended under the conditions set out in Article 5 of AMF Decision 2021-01 of 22 June 2021.

The liquidity contract will be implemented as of March 22, 2022, and may be terminated:

at any time by MaaT Pharma without notice
at any time by Kepler Cheuvreux, subject to thirty (30) calendar days’ notice
without notice and without formality if the shares are transferred to another stock market

On March 21, 2022 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that it will present a poster on the company’s anti-CD27 agonist antibody program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, taking place April 8-13, 2022 onsite in New Orleans, LA and online (Press release, Kineta, MAR 21, 2022, View Source;utm_medium=rss&utm_campaign=kineta-to-present-poster-on-anti-cd27-agonist-antibody-program-at-the-aacr-annual-meeting-2022 [SID1234610465]). Thierry Guillaudeux, PhD, EVP Research and Development at Kineta, will be presenting new preclinical data on the company’s anti-CD27 agonist antibodies in development for the treatment of blood cancers and solid tumors.

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Presentation Details

Title: CD27 a new immuno-oncology target shaping innate and adaptive anti-tumor immune responses
Abstract Number: 5588
Presenter: Thierry Guillaudeux, PhD
Session Type: In-Person and e-Poster Presentation
Session Title: Therapeutic Antibodies 3
Session Time: April 13, 2022 9:00AM – 12:30PM Central Time
Location: Poster Section 39

CD27 is a clinically validated drug target. It is a member of the TNF receptor superfamily and plays a critical role in T-cell activation by providing a co-stimulatory signal together with its ligand CD70. CD27 is highly expressed on naïve T cells and also provides a co-stimulatory signal for NK cell activation. Kineta has developed a diverse set of anti-CD27 agonist antibodies. They are fully human monoclonal antibodies (mAbs) that demonstrate low nM binding affinity to CD27 in humans. In preclinical studies, Kineta’s selected lead anti-CD27 agonist mAbs induce T cell proliferation, NK activation and secretion of cytokines involved in T cell priming and recruitment, demonstrating the ability to potentiate new anti-tumor responses. Kineta is in the final stage of lead selection and plans to nominate a clinical candidate in mid-2022.

On March 21, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that financial results for the fourth quarter and full year ended December 31, 2021, and overview of recent developments (Press release, UroGen Pharma, MAR 21, 2022, View Source [SID1234610461]).

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"I am proud of the progress we made in 2021 on behalf of patients as we’ve expanded access to Jelmyto and set the stage for important commercial and clinical milestones in the year ahead," said Liz Barrett, President and Chief Executive Officer of UroGen. "Our vision is to completely transform uro-oncology. With our enhanced capital position, solid adoption of Jelmyto in urothelial cancer, clinical progress in bladder cancer dosing patients in the single-arm pivotal Phase 3 ENVISION trial with UGN-102 and IND submission for UGN-301, our anti-CTLA4 antibody, we expect to deliver on that vision."

Business Highlights:

Jelmyto (mitomycin) for pyelocalyceal solution in low-grade Upper Tract Urothelial Cancer (LG-UTUC):

UroGen generated net product revenue of $16.2 million for the fourth quarter of 2021, representing 42% growth over the previous quarter and the highest quarter since launch.
As of March 1, 2022, 832 sites have been activated, completing their internal processes, and having treated or ready to treat patients. This represents an 18% increase since November 1, 2021.
Sites that have treated more than one patient as of March 1, 2022, increased to 106, compared to 86 as of November 1, 2021: an increase of approximately 23%.
Expanded pilot Named Patient Supply program with the addition of Australia to the previously announced five European countries.
Treated two patients in Israel, representing the first patients outside of the U.S. to receive Jelmyto in a commercial setting.
UGN-102 (mitomycin) for intravesical solution:

UroGen announced trial initiation and dosing of the first patient of the single-arm pivotal Phase 3 ENVISION trial of UGN-102 for the treatment of low-grade, intermediate risk non-muscle invasive bladder cancer (NMIBC). The study will enroll approximately 220 patients across 90 sites and is expected to complete enrollment by the end of 2022.
The trial is similar in design to the previously completed OPTIMA II study. Based on the results of the OPTIMA II study, the Company believes the ENVISION study carries a high probability of demonstrating a significant benefit for patients and, assuming positive findings, will be the basis of a New Drug Application (NDA) submission in 2024.
UGN-301 (zalifrelimab) for intravesical solution:

Reported positive nonclinical toxicology data for UGN-301, which formed the foundation of an Investigational New Drug Application (IND) submitted to the U.S. Food and Drug Administration (FDA), advancing plans to initiate a first-in-human, multi-arm, Phase 1 clinical study in the first half of 2022.
The Phase 1 study will evaluate the safety and tolerability of UGN-301 as monotherapy and in combination with other immunomodulators and chemotherapies in recurrent NMIBC. The first arm of the Phase 1 study will evaluate UGN-301 as monotherapy and will take approximately 12 months to complete.
UGN-301 is the Company’s anti-CTLA4 antibody in development through a strategic collaboration with the University of Texas MD Anderson Cancer Center and is intended for use as monotherapy and in combination with other immunomodulators and chemotherapies to treat high-grade NMIBC.
This clinical program represents the Company’s expansion into immunotherapy and intends to build upon encouraging nonclinical data showing that intravesical administration of anti-CTLA4 and a TLR agonist leveraging RTGel can produce a clinical benefit in a setting of high-grade bladder cancer.
Up to $100 Million Senior Secured Term Loan Facility with Funds Managed by Pharmakon Advisors

Announced the closing of an up to $100 million senior secured term loan facility (term loan facility) with funds managed by Pharmakon Advisors, L.P. (Pharmakon Advisors) expected to fund the Company’s continued product development, commercialization efforts, and other operations allowing the company to achieve breakeven cash flow by 2025, based on its current financial projections.
The first tranche of $75 million has been received with a second tranche of $25 million available to be drawn by the end of 2022.
Fourth Quarter 2021 Financial Results:

Jelmyto Revenue: UroGen reported net product revenue of Jelmyto for the fourth quarter 2021 of $16.2 million. Net product revenue was $48.0 million for the full year 2021, compared to $11.8 million in 2020 with the launch of Jelmyto in June 2020.

R&D Expense: Research and development expenses for the fourth quarter 2021 were $13.1 million, including non-cash share-based compensation expense of $0.9 million as compared to $12.4 million, including non-cash share-based compensation expense of $1.4 million, for the same period in 2020. Research and development expenses for the full year 2021 were $47.6 million, including non-cash share-based compensation expense of $4.0 million. This compares to $47.3 million, including non-cash share-based compensation expense of $6.4 million, for the full year 2020.

SG&A Expense: Selling, general and administrative expenses for the fourth quarter 2021 were $21.4 million, including non-cash share-based compensation expense of $4.5 million. This compares to $22.2 million, including non-cash share-based compensation expense of $5.1 million, for the same period in 2020. Selling, general and administrative expenses for the full year 2021 were $87.5 million, including non-cash share-based compensation expense of $19.1 million. This compares to $90.2 million, including non-cash share-based compensation expense of $21.6 million for the full year 2020.

Financing on Prepaid Forward Obligation: UroGen reported financing expense related to the prepaid forward obligation to RTW Investments of $7.3 million for the fourth quarter 2021. Financing expense related to the prepaid forward obligation to RTW Investments totaled $17.3 million for the full year 2021. The rate for 2022 will be 13% based on $48 million of global net product sales of Jelmyto in 2021.

Net Loss: UroGen reported a net loss of $28.5 million, or basic and diluted net loss per ordinary share of $1.27, for the fourth quarter 2021 as compared to $30.5 million, or basic and diluted net loss per ordinary share of $1.38, for the same period in 2020. UroGen reported a net loss of $110.8 million, or basic and diluted net loss per ordinary share of $4.96, for the full year 2021 versus $128.5 million, or basic and diluted net loss per ordinary share of $5.90, for the full year 2020.

Cash & Cash Equivalents: As of December 31, 2021, cash, cash equivalents and marketable securities totaled $89.8 million, and does not include the first tranche of the term loan facility.

2022 Revenue, Operating Expense and RTW Expense Guidance: The Company anticipates full year 2022 net product revenues from Jelmyto to be in the range of $70 to $80 million. The Company anticipates full year 2022 operating expenses in the range of $140 to $160 million, including non-cash share-based compensation expense of $10 to $16 million, subject to market conditions. The Company anticipates full year 2022 financing expense related to the prepaid obligation to RTW Investments in the range of $22 to $26 million, of which approximately $9.1 to $10.4 million will be in cash.

Conference Call & Webcast Information:

Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (855) 765-5685 (U.S.) or (615) 247-5916 (International) to listen to the live conference call. The conference ID number for the live call will be 7897224. An archive of the webcast will be available for two weeks on the Company’s website.

About Jelmyto

Jelmyto (mitomycin) for pyelocalyceal solution, is a drug formulation of mitomycin indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, Jelmyto is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. Jelmyto is delivered to patients using standard ureteral catheters or nephrostomy tube. The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC. On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.

APPROVED USE FOR JELMYTO

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.
Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
JELMYTO is given to your kidney through a tube called a catheter.
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

About Upper Tract Urothelial Cancer (UTUC)

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000 – 7,000 new or recurrent low-grade UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade intermediate risk NMIBC. Utilizing the RTGelTM Technology Platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter. The Company presented results from the Phase 2b OPTIMA II trial in September 2021.

About the Phase 3 ENVISION Trial

The Phase 3 ENVISION trial is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 (mitomycin) as primary chemoablative therapy in patients with low-grade, intermediate-risk NMIBC. The Phase 3 ENVISION trial is expected to enroll approximately 220 patients across 90 sites and study participants will receive six once-weekly intravesical instillations of UGN-102. The planned primary endpoint will evaluate the complete response rate at three months after the first installation, and the key secondary endpoint will evaluate durability over time in patients who achieve complete response at the three-month assessment. Based on discussions with the FDA, and enrollment expected by end of 2022, assuming positive findings, UroGen anticipates submitting an NDA for UGN-102 in 2024.

Learn more about the Phase 3 ENVISION trial at www.clinicaltrials.gov (NCT05243550)

About the Phase 3 ATLAS Trial

The Phase 3 ATLAS trial was a global, open-label, randomized controlled study designed to assess the efficacy and safety of UGN-102, with or without transurethral resection of bladder tumor (TURBT), versus TURBT alone in patients diagnosed with low-grade intermediate risk NMIBC, defined as 1 or 2 of the following: new or recurrent multifocal bladder tumors, a solitary new or recurrent tumor >3 cm, or low-grade intermediate risk NMIBC recurrence in less than 12 months following a prior tumor diagnosis requiring endoscopic surgical resection or ablation.

Patients were randomized 1:1 to either UGN-102 or TURBT. Patients in the UGN-102 arm were treated with six weekly intravesical instillations of UGN-102. At the three-month time point, patients were assessed for response. Patients who have demonstrated a complete response to either UGN-102 or TURBT, will continue for long-term follow-up for evidence of recurrence. Patients who demonstrate presence of persistent disease at three-months, in either arm, will undergo a TURBT and then will also continue for long-term follow up for evidence of recurrence. The primary endpoint of the study was disease free survival. On November 10, 2021, the Company announced that, following discussions with the FDA, it has ceased enrollment in the Phase 3 ATLAS trial and plans to initiate a new, single-arm Phase 3 study of UGN-102 in early 2022. All patients enrolled in the treatment arm of the Phase 3 ATLAS trial will continue to receive treatment and undergo follow up.

Learn more about the Phase 3 ATLAS trial at www.clinicaltrials.gov (NCT04688931)

On March 21, 2022 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, reported its annual results for the financial year to December 31, 2021, as approved by the Board of Directors on March 17, 2022 (Press release, Theradiag, MAR 21, 2022, View Source [SID1234610460]).

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Bertrand de Castelnau, CEO of Theradiag, commented: "The net result for the second half of 2021 was impacted by exceptional expenses associated with Covid test sales. Excluding the latter, Theradiag is continuing to close in on profitability thanks to its solid fundamentals and to good control over its operating costs on its core business. While the public health context remained difficult, these results emphasize the relevance of our strategic refocus, initiated in recent semesters, on innovation and the internationalization of our activities. Bolstered by an improved cost structure and a privileged positioning on the vast biotherapy market, we are today reaffirming our determination to accelerate Theradiag’s development on this market through the implementation of our new strategic plan that will enable us to improve all of our financial indicators."

"In 2021, despite the continuing uncertain economic and public health context, Theradiag was able to both maintain the commercial momentum and control the costs of its two historical activities. In 2022, we intend to accelerate our growth in order to reaffirm our leadership position on the biotherapy market and to develop new actives to support our expansion," added Pierre Morgon, Chairman of the Board of Directors.

Revenue up 6.8% despite a public health situation that remained delicate

Over the year to December 31, 2021, Theradiag recorded revenue of €11.1 million, versus €10.4 million in 2020, giving growth of 6.8% in line with the strategic priorities defined by the Company prior to November’s Rights Issue.

On the strength of the 21 i-Track10 or equivalent analyzers installed and active around the world, Theranostics activity recorded another excellent performance with growth of 12.7% in 2021, and now accounts for 52% of Theradiag’s business.

In Vitro Diagnostics (IVD) activity recorded a slight increase of 1.2% in revenue to €5.3 million.

Globally, Theradiag recorded solid performances in terms of exports and in the United States with growth of 25.9% and 17.0% respectively, reflecting the significant success of its overseas partnerships such as the one with Veracyte for the marketing of its tests in the United States.

Net result impacted, particularly in H2 2021, by exceptional expenses associated with its Covid activity; excluding exceptional items, Theradiag is continuing its progress towards profitability

In 2021, the decrease in Theradiag’s results was due to exceptional expenses associated with its Covid activity that was deployed in an opportunistic manner in 2020. As announced in its H1 2021 financial report, in the chapter on significant events after June 30, 2021, Theradiag decided to end its antigen activities. Following a number of appeals to the State’s highest authorities, Theradiag definitively cleared its stock of products. These expenses were assessed by the Company at approximately €500 thousand in 2021 and were primarily booked in the second half of 2021.

Excluding Covid, on its historical activities Theradiag was able to control its operating costs while maintaining its strategic investments in R&D and its commercial development in the United States, which drive its current and future growth. Hence, despite a 2021 operating loss of €879 thousand, excluding the losses associated with its Covid activity the operating momentum has been positive in recent years. Indeed, excluding these exceptional expenses, the operating loss was €383 thousand in 2021 compared with a loss of €596 thousand in 2020, with a significant improvement in profitability in the second half of 2021 with an operating loss excluding Covid sales expenses of just €58 thousand.

Overall, the net result excluding exceptional items and the net result totaled -€679 thousand and -€767 thousand respectively at December 31, 2021, versus -€181 thousand and -€231 thousand at December 31, 2020.

Comfortable cash position with the financing horizon ensured until end-2026

At December 31, 2021, Theradiag had a net cash position of €7.1 million, compared to €1.4 million at June 30, 2021; for the last year or so, the Company has been able to stabilize its cash position at around €2 million, excluding capital increase. Henceforth, following the Rights Issue carried out in November, the Company has a financing horizon through to 2026 and thus has medium-term financial autonomy.

Reminder of the Company’s 2021 highlights

CE marking for the new TRACKER range i-Tracker test kits: Vedolizumab and Ustekinumab kits on originator and biosimilar molecules;
Signing of a contract to supply quality control reagents to Orgentec, a specialist in in vitro diagnostics, notably in autoimmunity and infectious diseases;
Participation in Humabdiag, a large-scale research project undertake with the University of Tours and the University Hospital of Tours targeting the bioproduction of monoclonal antibodies notably for Theradiag and the entire biotherapy market;
€5.33 million Rights Issue;
Launch of four new i-Tracker kits and validation of a new parameter in the United States: Golimumab and Rituximab kits.
Significant event since the end of 2021

Signing of a distribution agreement with BIOSYNEX for their AMPLIQUICK SARS-CoV-2 PCR test in January 2022

An initial two-year distribution agreement was signed between THERADIAG and BIOSYNEX for the AMPLIQUICK SARS-CoV-2 PCR test from BIOSYNEX, which will be promoted in hospitals by THERADIAG, which enjoys a strong presence in hospitals, and notably in the vast majority of University Hospitals.

As an extension of this first contract, BIOSYNEX and THERADIAG intend to explore opportunities to develop joint projects.

Financial calendar:

Annual General Meeting, Thursday May 5, 2022
H1 2022 revenue, Monday July 18, 2022
H1 2022 results, Monday September 19, 2022