Augmedix Announces Successful Completion of Debt Refinancing

SAN FRANCISCO, March 30, 2021 (GLOBE NEWSWIRE) — Augmedix, Inc. (“Augmedix”), a leading provider of remote medical documentation and live clinical support, announced that it has refinanced its long-term debt obligations through a secured term loan with Eastward Capital Partners.

The new loan facility consists of a $15 million secured term loan and $2 million available in 4Q21 upon the achievement of certain financial objectives. A portion of the proceeds from the term loan were used to pay down $13.0 million of the Company’s existing long-term debt and associated fees as of December 31, 2020, with the remaining being used for working capital and general corporate purposes.

“We are happy to announce the refinancing, which enhances our balance sheet and significantly extends our operating runway,” said Paul Ginocchio, Chief Financial Officer of Augmedix. “Our recent fourth quarter 2020 capital raise, and OTCQX listing, combined with our strong financial performance, speak to a bright future for our company and our clinician partners. The refinancing provides us with greater flexibility to support the execution of our growth strategy. It has been great to team up with Eastward Capital Partners.”

“Eastward Capital Partners is pleased to support Augmedix’s differentiated offering, growth plans, and strong management team,” said Tim O’Loughlin, Investment Partner at Eastward Capital Partners. “We were attracted by Augmedix’s large addressable market and great execution. Eastward is excited to partner with Augmedix on its mission to rehumanize the clinician-patient relationship.”

Additional details regarding the Company’s new term loan agreement are set forth in its Current Report on Form 8-K, filed with the Securities and Exchange Commission on March 30, 2021.

About Eastward Capital Partners

Founded in 1994, Eastward Capital Partners is a provider of private debt financing to technology enabled companies. Since its inception, Eastward has provided financing solutions to more than 220 companies across industries including Software, Communications, Healthcare Technology, Business Services and New Media. Eastward Capital Partners is based in West Newton, Massachusetts.

About Augmedix

Augmedix converts natural clinician-patient conversation into medical documentation and provides live support, including referrals, orders, and reminders, so clinicians can focus on what matters most: patient care. The Augmedix platform is powered by a combination of proprietary automation modules and human-expert assistants operating in HIPAA-secure locations to generate accurate, comprehensive, and timely-delivered medical documentation. Augmedix services are compatible with over 35 specialties and are trusted by over one dozen American health systems and hundreds of independent clinicians supporting medical offices, clinics, hospitals and telemedicine. We estimate that our solution saves clinicians 2–3 hours per day, increases productivity by as much as 20%, and increases clinicians’ satisfaction with work-life balance over 40%. To learn more about Augmedix, visit augmedix.com.

Forward Looking Statements

This press release contains “forward-looking statements” that involve a number of risks and uncertainties, including but not limited to our expectations for growth and quotation on the public markets. Words such as “believes,” “may,” “will,” “estimates,” “potential,” “continues,” “anticipates,” “intends,” “expects,” “could,” “would,” “projects,” “plans,” “targets,” and variations of such words and similar expressions are intended to identify forward-looking statements. Forward-looking statements are based on management’s expectations as of the date of this filing and are subject to a number of risks, uncertainties and assumptions, many of which involve factors or circumstances that are beyond our control. Our actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in our prospectus filed with the Securities and Exchange Commission on February 8, 2021 as well as other documents that may be filed by us from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: our expectations regarding changes in regulatory requirements; our ability to interoperate with the electronic health record systems of our customers; our reliance on vendors; our ability to attract and retain key personnel; the competition to attract and retain remote documentation specialists; anticipated trends, growth rates, and challenges in our business and in the markets in which we operate; our ability to further penetrate our existing customer base; our ability to protect and enforce our intellectual property protection and the scope and duration of such protection; developments and projections relating to our competitors and our industry, including competing dictation software providers, third-party, non-real time medical note generators and real time medical note documentation services; the impact of current and future laws and regulations; the impact of the COVID-19 crisis on our business, results of operations and future growth prospects. Past performance is not necessarily indicative of future results. The forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. We undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Investors:

Caroline Paul
Gilmartin Group
[email protected]

Media:

Kaila Grafeman
Augmedix
[email protected]



CW Petroleum Corp (CWPE): SEC Qualifies CW Petroleum Corp Reg A+ Public Offering

Katy, Texas, March 30, 2021 (GLOBE NEWSWIRE) — CW Petroleum Corp (OTCQB: CWPE), a leading provider of Proprietary No-Ethanol Gasoline and Biofuels, today announced that effective March 15, 2021, the Securities and Exchange Commission (“SEC”) declared its Form 1-A offering statement qualified.

The Company may now proceed with its plan to publicly offer up to $50,000,000 of Common Stock at a price of $0.75 per share, to qualified investors in a Reg A+ public offering.

The funding from this offering will be used to execute the company’s long-term expansion of its existing sales of Reformulated No Ethanol Gasoline based on Isobutanol, Biofuels, Refined Products Trading Operations and the purchase of Convenience Stores to realize increased profits from the retailing of its diversified fuel products.

Please see the Company’s Qualified Offering Circular at: CWPE SEC Form 253G1

For additional information, visit our website at cwpetroleumcorp.com or call 281-817-8099

About CW Petroleum Corp

CW Petroleum Corp supplies and distributes Biodiesel, Biodiesel Blends, Ultra Low Sulfur Diesel Fuel, Gasoline, and a Proprietary EPA Approved Reformulated No Ethanol Gasoline to distributors, retail stations, marinas and end-users.

Forward-Looking Statements

Certain statements in this press release may contain “forward-looking statements” regarding future events and our future results. All statements other than statements of historical facts are statements that could be deemed to be forward-looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the markets in which we operate and the beliefs and assumptions of our management. Words such as “expects,” “anticipates,” “targets,” “goals,” “projects”, “intends,” “plans,” “believes,” “seeks,” “estimates,” “endeavors,” “strives,” “may,” or variations of such words, and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements are subject to a number of risks, uncertainties and assumptions that are difficult to predict, estimate or verify. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Such risks and uncertainties include those factors described in the Company’s most recent annual report on Form 1-K, as such may be amended or supplemented by subsequent semiannual reports on Form 1-SA, or other reports filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements. For more information, please refer to the Company’s filings with the Securities and Exchange Commission.



Silence Therapeutics Reports Full-year 2020 Results

Silence Therapeutics Reports Full-year 2020 Results

Advancing clinical programmes; On-track for three phase 1 data readouts in 2021

30 March 2021

LONDON, Silence Therapeutics plc, AIM: SLN and Nasdaq: SLN (“Silence” or “the Company”), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, announced its audited full year results for the year ended 31 December 2020.  

Mark Rothera, President and CEO of Silence Therapeutics, commented:
“2020 was a transformational year for Silence Therapeutics, driven by the remarkable resilience of our people in what was a challenging year for the world. We have made significant progress with our mRNAi GOLD™ platform, with both lead programmes now in the clinic and three data readouts due this year. Alongside advancing our wholly owned pipeline, we continue to progress our high-value partnerships and through this two-pronged approach, our goal is to deliver 2-3 INDs per year from 2023. We are well positioned for success and motivated by our vision to transform people’s lives through our precision engineered medicines.”

Craig Tooman, CFO of Silence Therapeutics, commented:
“Silence ended 2020 in a strong financial position, driven by non-dilutive funding from our collaborations. Our balance sheet has been further strengthened by the recent $45 million financing, which demonstrated the growing appreciation for Silence and expanded our global shareholder base. We will look to build upon this in 2021 as we continue to enhance our capabilities and maximise the opportunity of our mRNAi GOLD™ platform.”

Operational Highlights

  • Advanced both wholly owned product candidates, SLN360 for cardiovascular disease due to high Lipoprotein(a), or Lp(a) levels and SLN124 for thalassaemia and myelodysplastic syndrome (MDS).
    • SLN360 received approval of an initial drug application (IND) by the FDA and Silence initiated the APOLLO Phase 1 study in people with high Lp(a) levels.
    • SLN124 was granted rare paediatric disease designation for thalassaemia as well as orphan drug designations for MDS and thalassaemia by the FDA.
    • Initiated the GEMINI Phase 1 study of SLN124 in healthy volunteers.
  • Secured a significant collaboration deal with AstraZeneca to discover and develop siRNA therapeutics for up to 10 targets in cardiovascular, renal, metabolic and respiratory diseases.
    • Upfront cash payment of $20m was received and another $40m is due in the first half of 2021.
    • Deal economics include up to $400m in milestone payments and royalties for each programme.
  • Expanded RNAi collaboration with Mallinckrodt for complement-mediated diseases with Mallinckrodt exercising options to license two additional targets from Silence, bringing the total to the maximum three programmes envisaged in the collaboration deal.
  • Commenced a technology evaluation with Takeda to explore the potential of using Silence’s mRNAi GOLD™ platform against a novel, undisclosed target.
  • Appointed Dr Giles Campion as Executive Director, Dr Marie Wikström Lindholm as Senior Vice President, Molecular Design, Dr Eric Floyd as Senior Vice President, Head of Global Regulatory Affairs and Quality Assurance and Dr Barbara Ruskin as Senior Vice President, General Counsel and Chief Patent Officer.
  • Launched a Scientific Advisory Board comprising world-leading scientists and clinicians to support the optimisation of Silence’s mRNAi GOLD™ platform and guide development strategies for SLN360 and SLN124.
  • Completed U.S. listing and our American Depository Shares (ADSs) began trading on the Nasdaq Capital Market (Nasdaq) under the symbol “SLN” on 8 September 2020.
  • Appointed Mark Rothera as our President, Chief Executive Officer and Board member.

Financial Highlights

  • Cash and cash equivalents and term deposits of £37.4m at year-end (2019: £33.5m). The Group had £97.5m on a proforma basis, which includes £37.4m at year-end, plus the £29.3m ($40m) receivable from AstraZeneca due in the first half of 2021, plus net proceeds of £30.8m from the February 2021 capital raise.
  • Cash flow from operating activities was £10.8m outflow (2019: £1.7m inflow) against an operating loss of £35.8m (2019: £22.7m). 2020 included receipts of $20m upfront from AstraZeneca, $2.0m in milestones from Mallinckrodt Pharmaceuticals, and a $2.0m upfront from Takeda.
  • 2020 loss was higher primarily due to increased research and development spend in relation to our SLN360 and SLN124 proprietary programmes, as well as general and administrative expenses mainly relating to the Nasdaq listing.

Post Year-end

  • Appointed Dr Michael H. Davidson to the Silence Board of Directors as a Non-Executive Director and Craig Tooman to the Executive Leadership Team as Chief Financial Officer.
  • Completed an oversubscribed $45m (c. £33m) private placement led by top-tier US institutional healthcare funds.  
  • Initiated dosing in the APOLLO Phase 1 study of SLN360 in people with high Lp(a) levels.
  • Initiated work with Mallinckrodt on the third complement target which triggered a $2.0m research milestone payment to Silence.
  • Completed enrolment in the GEMINI Phase 1 study of SLN124 in healthy volunteers.
  • Initiated the GEMINI II Phase 1b study of SLN124 in people with thalassemia and MDS.

Enquiries:

Silence Therapeutics plc

Gem Hopkins, Head of IR and Corporate Communications
[email protected]

 

Tel:  +1 (646) 637-3208
 
Investec Bank plc
(Nominated Adviser and Broker)

Daniel Adams/Gary Clarence

 

  Tel:  +44 (0) 20 7597 5970
European PR

Consilium Strategic Communications

Mary-Jane Elliott/ Angela Gray / Chris Welsh
[email protected]

 

Tel: +44 (0) 20 3709 5700

About Silence Therapeutics

Silence Therapeutics is developing a new generation of medicines by harnessing the body’s natural mechanism of RNA interference, or RNAi, to inhibit the expression of specific target genes thought to play a role in the pathology of diseases with significant unmet medical need. Silence’s proprietary messenger RNAi GOLD™ platform can be used to create siRNAs that precisely target and silence disease-associated genes in the liver, which represents a substantial opportunity. Silence’s wholly owned product candidates include SLN360 designed to address the high and prevalent unmet medical need in reducing cardiovascular risk in people born with high levels of lipoprotein(a) and SLN124 designed to address iron loading anemias. Silence also maintains ongoing research and development collaborations with AstraZeneca, Mallinckrodt Pharmaceuticals, and Takeda, among others. For more information, please visit https://www.silence-therapeutics.com/.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements, including with respect to the Company’s clinical and commercial prospects. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

Conference Call

Company management will host a live webcast to discuss its 2020 annual results and recent business performance today at 8:00 a.m. EDT / 13:00 BST.

Dial-in details are:

Webcast link: https://edge.media-server.com/mmc/p/odvo7f8f

Participant UK dial-in: +44 2071 928338
Participant US dial-in: +1 646 741 3167
Conference ID: 3094621

A presentation to accompany the call will be made available to download from; https://www.silence-therapeutics.com/investors/results-reports-presentations

Chairman’s Statement

That was the year that was….

As I write this, we are still in the midst of the COVID-19 pandemic. No business has been left untouched by the impact of the virus, and at Silence Therapeutics, we have effectively taken all necessary steps to reduce the potential negative impact on our business. Most importantly, our priority in the current situation has been to ensure the well-being and safety of our employees, patients, and partners, whilst conscientiously safeguarding the interests of you, our shareholders. Accordingly, we have taken the necessary precautions and we will continue to monitor the spread of the virus and implement subsequent actions carefully so the business is in its strongest possible position to maximise the opportunity when the international vaccination programmes are rolled out and restrictions are finally lifted. During the period under review, our employees have done an amazing job to maintain the integrity of our business despite the unprecedented conditions. 

The pace has quickened….

In last year’s Annual Report, I made it clear I thought that “Silence had come of age”. This was clearly demonstrated in the second half of 2019 and throughout 2020 and I can confirm the pace has quickened. We have made significant progress across all facets of the business as outlined in this year’s CEO’s Report. Notably, our R&D organisation and capabilities have been significantly strengthened and the development of our potentially world-class clinical assets progressed. Independently and together with our business partners, we have ongoing clinical trials and clinical trials planned to start. However, we recognise that global measures against COVID-19 and the need to prioritise health care resources have undoubtedly affected the timelines of these studies. As a result, we have put in place contingency measures and although the timing of the initial results from clinical studies may be affected, we remain confident that in 2021 we are well placed to expediently progress our wholly owned SLN360 and SLN124 programmes and our partnered programmes and achieve significant clinical milestones.

During the year we have concluded additional pivotal partnering agreements with big pharma including AstraZeneca, and also with biotech and academic groups and thereby not only accessed capabilities and assets but also considerably strengthened our balance sheet by securing further non-dilutive funding. In parallel, as we have achieved further clinical and regulatory milestones for each of our wholly owned programmes, there has been a growing excitement amongst researchers, clinicians, patient groups and further potential partners.  

A competent and cohesive team is now in place……

During the year we opened our office in New York and listed on Nasdaq and made further key management appointments across the organisation. In September 2020 we appointed our new CEO, Mark Rothera, who brings the experience we need to capitalise on the progress to date and to build the business going forward. Despite the backcloth of COVID-19, in 2020, Silence Therapeutics was designated a Great Place to Work both in the UK and Germany, which is a further testament to our management and employees with their high level of competence and commitment.

Governance….

We remain committed to high standards of governance and continue to comply with the regulatory standards required of an AIM listed and Nasdaq foreign private issuer (“FPI”) company. Also, we are committed to an effective control environment to maintain high standards throughout the Company. In addition to appointing our new CEO, during the year we invited Dr Giles Campion, Head of R&D and CMO to join the Board as an Executive Director to ensure R&D remains at the front and centre of our thinking. Post period we further strengthened the Board with the appointment of Dr Michael Davidson as Non-Executive Director. Michael brings relevant clinical experience in the cardiovascular sector and also an extensive background in the US biotech sector.

Outlook – it is now about execution….

This past year has not been without its challenges, but with the continued support of our major shareholders and the dedication of a highly resilient and focused management team, I am confident by executing on our strategy in relation to our pipeline delivery, portfolio focus, geographic expansion and commercial goals that we now have the momentum, and ability to deliver on our ambitious targets for 2021 and beyond. 

On behalf of the business, I want to extend our thanks to all our stakeholders, shareholders, partners and suppliers, who have supported the business over the past year. As a final word, I would like to share my sincere thanks to our employees for their hard work and commitment in 2020. With their dedication and determination, we have navigated a transformational journey, and during the COVID-19 era, which has enabled us to achieve our goals for the Company while setting a foundation to deliver long-term advantage. I am proud of their achievements and look forward to working with them on the next stage of our journey in 2021.

Iain Ross
Chairman

Chief Executive Officer’s Report

2020 was a transformational year for Silence, highlighted by remarkable scientific and corporate progress. After 20 years of developing our science in the field of RNAi, we enter 2021 as a clinical-stage company with three Phase 1 data readouts anticipated this year. Since joining the Company in September 2020, I have been immensely impressed with our innovative science, unparalleled know-how and the dedication of our team. I believe Silence is poised for substantial growth and our team is focused on strong execution with a clear near-term path to value creation.

Exceptional progress…

Silence is showing rapid progress towards realizing our potential with several important milestone achievements in 2020 and this progress has continued at pace in 2021. In 2020, we made significant progress with our proprietary mRNAi GOLD™ (GalNAc OLigonucleotide Discovery) platform, advancing both wholly owned candidates, SLN360 for the high and prevalent unmet need in reducing cardiovascular risk due to high lipoprotein(a) – Lp(a) – levels and SLN124 for rare iron loading anaemia conditions thalassemia and MDS.

In the year, SLN360 received approval of an investigational new drug application (IND) from the FDA and we initiated the APOLLO Phase 1 study in people with high Lp(a), a genetically determined independent cardiovascular risk factor affecting up to 20% of the world’s population. We also made significant progress with SLN124, which was granted rare paediatric disease designation for thalassaemia and orphan drug designation for MDS and adults with thalassaemia by the FDA. In the year, we were also pleased to initiate the GEMINI Phase 1 study of SLN124 in up to 24 healthy volunteers. Both assets are now in the clinic with three Phase 1 data readouts anticipated in 2021.

Alongside advancing our wholly owned pipeline, developing high-value collaborations is a core part of our strategy and we made great strides with this in 2020. This included a landmark deal with AstraZeneca for up to 10 programmes, a technology evaluation deal with Takeda for a first programme as well as deepening our collaboration with Mallinckrodt for complement-mediated diseases with Mallinckrodt exercising options on all three programmes covered by the agreement. Collectively these partnerships represent up to 14 programmes and economics of up to $6 billion in potential milestones plus royalties.

The completion of our Nasdaq listing in September marked a significant step in our efforts to position ourselves more globally and gives us access to an important pool of capital, US biotech investors. Financially, we ended the year with a strong cash position of £37.4m, driven by payments received from our collaborations, particularly the $20m upfront from AstraZeneca. Combined with the capital raise we completed in February 2021 and payment due from AstraZeneca in the first half of 2021, we have a proforma cash balance of £97.5m. 

The right people…

You can have the best science and technology in the world, but it does not matter if you do not have the right people and culture in place to execute your strategy. At Silence, I believe we have both. We have exceptional experience at every level, including a research and discovery team that has been operating now for 20 years in the RNAi field. In the year, we strengthened our executive leadership team, including appointments such as Dr Giles Campion as Executive Director, Dr Eric Floyd as Senior Vice President, Head of Global Regulatory Affairs and Quality Assurance, Dr Barbara Ruskin as Senior Vice President, General Counsel and Chief Patent Officer and Dr Marie Wikström Lindholm as Senior Vice President, Molecular Design. We also introduced a Scientific Advisory Board comprising world-leading scientists and clinicians to support the optimisation of our mRNAi GOLD™ platform and guide development strategies for SLN360 and SLN124. This momentum has continued into 2021 as we have appointed leading lipidology and cardiovascular clinical trial expert, Dr Michael Davidson, to our Board of Directors and Craig Tooman, an experienced US public biotech company CFO to our leadership team.

A clear path to value creation…

It has taken a number of years for the RNA field to mature, and we have enjoyed watching it soar over the past year, highlighted by the FDA approval of two mRNA-based vaccines for COVID-19. There is more awareness and increasing appreciation for the potential benefits of mRNA-based therapeutics and I believe that Silence is well positioned to capitalise on this attractive market.

Over the years, Silence has built substantial know-how and expertise in the science of RNAi, which has given rise to our mRNAi GOLD™ platform that is now in the clinic. Since I joined Silence, we have conducted a detailed strategic business review and identified three core components of our strategy going forward – all based on our mRNAi GOLD™ platform.

Firstly, we must rapidly and effectively execute on our clinical programmes. We view SLN360 as a key strategic asset as this is a program with blockbuster potential that we own outright. We are hopeful that the strong pre-clinical profile will translate well into the clinic and expect to report data from the ongoing APOLLO Phase 1 study of SLN360 in people with high Lp(a) in the second half of this year. Our plan is to rapidly advance SLN360 in the clinic, positioning ourselves to initiate phase 2 studies in the second half of 2022 while creating more value for the asset and options for the future. With SLN124, we expect data from the ongoing GEMINI Phase 1 study in healthy volunteers in the first half of this year. This study is important because we expect it to validate our preclinical findings that administering SLN124 effectively reduces iron overload by increasing hepcidin levels and it will be the first-in-human data from our mRNAi GOLD™ platform. In parallel, we are evaluating SLN124 in the GEMINI II Phase 1b study in people with thalassemia and MDS and intend to report interim data from the single-ascending dose portion in the second half of this year.

Next, we must ensure that we fully unleash the potential of our mRNAi GOLD™ platform. There are around 14,000 genes expressed in the liver and only around 1% of those genes are currently being targeted by a RNAi program. To address this untapped opportunity, we are taking a two-pronged approach to target selection – pursuing both best-in-class and first-in-class opportunities that are focused in areas of significant unmet need with clear commercial opportunity. We intend to accelerate our discovery efforts to enable 2-3 INDs per year starting in 2023, including wholly owned plus partnership programmes.

Finally, we will continue with our hybrid business model, building our wholly owned pipeline while developing partnership programs that allow us to do more with our mRNAi GOLD™ platform. This hybrid approach creates a balance to rapidly grow our pipeline while enabling us to finance our endeavours largely through non-dilutive capital from partnership programmes. We believe this is especially worthwhile given the unusually high probability of success this modality has shown in the clinic amongst RNAi players.

Looking ahead…

I believe that this is our moment. We have deep scientific know-how in the RNAi field, two wholly owned programmes advancing in the clinic, validating partnerships, and a platform technology that is really at the beginning of what it can do. Importantly, we have the right team to drive execution. Our goal now is to effectively accelerate this development and position Silence as a leading global RNAi business.

We are truly motivated by our purpose to transform peoples’ lives around the world through our precision engineered medicines and driving positive change for the communities around us. I look forward to keeping you updated on our progress.

Mark Rothera

Chief Executive Officer

Financial Review

Investment in R&D grew strongly in the year to £20.2m, reflecting the excellent progress made in advancing SLN360 and SLN124 towards the clinic. We ended the year with £37.4m in cash, cash equivalents and term deposits. In addition, we received net proceeds of £30.8m post year-end in a capital raise and will receive £29.3m ($40m) from AstraZeneca in the first half of 2021. In total, this gives us £97.5m on a proforma basis, and sufficient resources to deliver clinical data using our
mRNAi GOLD™ platform in 2021

Revenue

Revenue recognised for 2020 increased to £5.5 million (2019: £0.2m), driven by partial recognition of upfront, milestone payments, and recharges relating to the collaboration with Mallinckrodt, AstraZeneca and Takeda as well as royalty income from Alnylam Pharmaceuticals. The balance of the upfront, milestone and recharge amounts will be recognised as revenue in future years over the period which services are provided.

Research and Development Expenditure

Research and development spend in the year increased by £6.9m to £20.2m (2019: £13.3m), primarily driven by an increase in third party and personnel costs needed to support the advancement of both SLN360 and SLN124 into clinical studies as well as new partnership programmes with AstraZeneca, Takeda and Mallinckrodt.

Administrative Expenses

General and administration expenses increased by £4.4m to £14.0m for 2020 (2019: £9.6m), primarily driven by additional finance and legal costs associated with the Nasdaq listing in September 2020.

Other (Losses)/Gains

The Group recognised an expense of £3.4m for 2020 (2019: £nil) mainly due to £4.9m of foreign exchange losses resulting from revaluation of foreign currency denominated monetary items, offset by a £1.5m gain on the fair value of derivative forward contract.

Finance and Other Income

The Group recognised income of £0.1m for 2020 (2019: £0.02m) in respect of bank interest receivable.

Finance and Other Expenses

The Group recognised an expense of £0.3m for 2020 (2019: £0.2m) mainly due to foreign exchange losses resulting from revaluation of foreign currency denominated monetary items.

Taxation

Taxation for 2020 amounted to a credit of £3.5m compared to £3.3m for 2019, primarily reflecting the increase in our R&D expenses. During the year, the Group received a research and development tax credit of £3.0m in the UK in respect of R&D expenditure in 2019. The Group recognised a £3.5m credit in the profit and loss account and £3.5m current tax asset in relation to 2020 research and development tax credits.

The increase in the credit amount was primarily attributable to our increased expenditure on research and development.

Liquidity, Cash and Cash Equivalents and Term Deposits

The Group’s cash and cash equivalents and term deposits at year end totalled £37.4m (2019: £33.5m).

The cash flow from operating activities was £10.8m outflow (2019: £1.7m inflow) against an operating loss of £35.8m (2019: £22.7m). 2020 included receipts of $20m upfront from AstraZeneca, $2.0m in milestones from Mallinckrodt Pharmaceuticals, and a $2.0m upfront from Takeda.

In 2021, the Group expects to make continued investments in R&D to support its clinical programmes and discovery efforts. The Group also anticipates increased G&A investments compared to FY 2020 to support organisational growth, including its public company needs.

The Directors have reviewed the working capital requirements of the Group and Company for the twelve months from signing these financial statements and are confident that these can be met from existing funds, which also takes into account the $45.0m raised in February 2021 and the $40.0m due from AstraZeneca in the first half of 2021.

Other Balance Sheet Items

Current trade and other payables increased by £1.3m to £8.2m at the end of 2020 (2019: £6.9m). This was driven by increased contract research organisation (CRO) costs due to ramp up in activities associated with our SLN360 and SLN124 clinical development programmes.

Craig Tooman
Chief Financial Officer

Consolidated income statement

year ended 31 December 2020

          2020     2019  
            £000s     £000s  
Revenue             5,479       244  
Cost of sales             (3,762 )      
Gross (loss) / profit             1,717       244  
Research and development costs             (20,209 )     (13,336 )
Administrative expenses             (13,983 )     (9,642 )
Other (losses)/gains – net             (3,372 )      
Operating loss             (35,847 )     (22,734 )
Finance and other expenses             (323 )     (163 )
Finance and other income             129       27  
Loss for the year before taxation             (36,041 )     (22,870 )
Taxation             3,494       3,288  
Loss for the year after taxation             (32,547 )     (19,582 )
Loss per ordinary equity share (basic and diluted)             (39.8 ) pence     (26.1 ) pence

Consolidated statement of comprehensive income

year ended 31 December 2020

    2020     2019  
    £000s     £000s  
Loss for the year after taxation     (32,547 )     (19,582 )
Other comprehensive expense, net of tax:                
Items that may subsequently be reclassified to profit and

   loss:
               
Foreign exchange differences arising on consolidation of foreign
   operations
    472       (411 )
Total other comprehensive income/(expense) for the year     472       (411 )
Total comprehensive expense for the year     (32,075 )     (19,993 )

Consolidated balance sheet

at 31 December 2020

            December 31,  
          2020     2019  
            £000s     £000s  
Non-current assets                        
Property, plant and equipment             1,127       611  
Goodwill             8,125       7,692  
Other intangible assets             17       34  
Financial assets at amortised cost             303       275  
              9,572       8,612  
Current assets                        
Cash and cash equivalents             27,449       13,515  
Derivative financial instrument             1,492        
Financial assets at amortised cost – term deposit             10,000       20,000  
Financial asset at amortised cost – other                   1  
R&D tax credit receivable             3,536       3,060  
Other current assets             4,616       885  
Trade receivables             29,306       4  
              76,399       37,465  
Non-current liabilities                        
Contract liabilities             (51,337 )     (15,515 )
              (51,337 )     (15,515 )
Current liabilities                        
Contract liabilities             (17,042 )     (2,478 )
Trade and other payables             (8,192 )     (6,888 )
Lease liability             (341 )     (287 )
              (25,575 )     (9,653 )
Net assets             9,059       20,909  
Capital and reserves attributable to the owners of the parent                        
Share capital             4,165       3,919  
Capital reserves             186,891       167,243  
Translation reserve             2,218       1,746  
Accumulated losses             (184,215 )     (151,999 )
Total shareholders equity             9,059       20,909  

Consolidated statement of changes in equity

year ended 31 December 2020

        Share

capital
    Capital

reserves
    Translation

reserve
    Accumulated

losses
    Total

equity
 
        £000s     £000s     £000s     £000s     £000s  
At January 1, 2019         3,554       163,121       2,157       (133,787 )     35,045  
Recognition of share-based payments               584                   584  
Options exercised in the year               (1,370 )           1,370        
Proceeds from shares issued         365       4,908                   5,273  
Transactions with owners recognised

   directly in equity
        365       4,122             1,370       5,857  
Loss for year                           (19,582 )     (19,582 )
Other comprehensive expense                                            
Foreign exchange differences arising on
   consolidation of foreign operations
                    (411 )           (411 )
Total comprehensive expense for the year                     (411 )     (19,582 )     (19,993 )
At December 31, 2019         3,919       167,243       1,746       (151,999 )     20,909  
Recognition of share-based payments               4,395                   4,395  
Options exercised in the year               (331 )           331        
Proceeds from shares issued         246       15,584                   15,830  
Transactions with owners recognised directly

   in equity
        246       19,648             331       20,225  
Loss for year                           (32,547 )     (32,547 )
Other comprehensive income                                          
Foreign exchange differences arising on
   consolidation of foreign operations
                    472             472  
Total comprehensive expense for the year                     472       (32,547 )     (32,075 )
At December 31, 2020         4,165       186,891       2,218       (184,215 )     9,059  

Consolidated statement of cash flows

year ended 31 December 2020

    Year ended December 31,  
    2020     2019  
    £000s     £000s  
Cash flow from operating activities                
Loss before tax     (36,041 )     (22,870 )
Depreciation charges     476       452  
Amortisation charges     20       30  
Charge for the year in respect of share-based payments     4,395       584  
Net foreign exchange loss     4,864        
Gain on derivative financial instrument     (1,492 )      
Finance and other expenses     323       163  
Finance and other income     (129 )     (27 )
(Gain)/loss on disposal of property, plant and equipment     (3 )     2  
Revaluation of trade and other receivables related to contract liabilities     (4,864 )      
Decrease in trade and other receivables     (29,302 )     (4 )
Increase in other current assets     (3,731 )     (4 )
Decrease in current financial assets at amortised cost – other     1       42  
Increase in trade and other payables     1,303       3,058  
Increase in contract liabilities     50,386       17,993  
Cash spent on operations     (13,794 )     (581 )
R&D tax credits received     3,018       2,308  
Net cash (outflow)/inflow from operating activities     (10,776 )     1,727  
Cash flow from investing activities                
Net redemption/(purchase) of financial assets at amortised cost – term deposits     10,000       (15,000 )
Interest received/(paid)     129       (6 )
Purchase of property, plant and equipment     (511 )     (9 )
Purchase of intangible assets     (3 )      
Proceeds from sale of property, plant and equipment     3        
Net cash inflow/(outflow) from investing activities     9,618       (15,015 )
Cash flow from financing activities                
Repayment of lease liabilities     (402 )      
Proceeds from issue of share capital     15,830       5,273  
Net cash inflow from financing activities     15,428       5,273  
Increase/(decrease) in cash and cash equivalents     14,270       (8,015 )
Cash and cash equivalents at start of year     13,515       21,494  
Effect of exchange rate fluctuations on cash and cash equivalents held     (336 )     36  
Cash and cash equivalents at end of year     27,449       13,515  



Immatics Announces Full Year 2020 Financial Results and Corporate Update



  • Phase 1a data update from clinical ACTengine® programs demonstrated first anti-tumor activity at early phases of dose escalation in heavily pre-treated solid cancer patients



  • Enrollment across clinical ACTengine® IMA200 trial series continues to scale up



  • Cash and cash equivalents as well as other financial assets of $285 million

    1

    (
    €232
    million)
    as of December 31, 2020 provide cash reach into 2023

Tuebingen, Germany and Houston, TX, March 30, 2021 – Immatics N.V. (NASDAQ: IMTX; “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, today provided an update on its corporate progress and reported financial results for the quarter and full year ended December 31, 2020.

Harpreet Singh, Ph.D., CEO of Immatics commented, “The past year was exceptional for Immatics with the advancement of our pipeline programs, expansion of our leadership team and scientific advisory board and the completion of our listing on the Nasdaq. Building on this foundation, we have recently delivered encouraging data from three clinical TCR-T studies demonstrating first anti-tumor activity in heavily pre-treated solid cancer patients. This early data also constitutes a first clinical validation for our differentiated TCR therapeutics platform. We look forward to reporting further data from our Phase 1 ACTengine® TCR-T trials as well as the progress in our TCR Bispecifics programs (TCER®) in the latter part of this year.”

Fourth Quarter 2020 and Subsequent Company Progress



Adoptive Cell Therapy Programs

  • ACTengine® IMA200 series – Immatics provided a clinical data update from three ongoing ACTengine® Phase 1 trials for its engineered Adoptive Cell Therapy approach (also known as TCR-T) in March. The combined data readout during early phases of dose escalation for the ACTengine® programs, IMA201, IMA202 and IMA203, indicated first anti-tumor activity with tumor shrinkage observed in 8 out of 10 patients including one unconfirmed partial response as of data cut-off. This was consistent with the observed robust engraftment, persistence and tumor infiltration of infused ACTengine® T cells. Overall, all product candidates demonstrated a manageable safety and tolerability profile. An additional Phase 1a read-out for IMA201 and IMA203 and initial Phase 1b data for IMA202 from the dose expansion cohort is planned for H2 2021. Submission of a clinical trial application (CTA) for the fourth IMA200 series program, IMA204, remains anticipated for H2 2021. The company presented the first preclinical data for the program in September 2020, which is directed at a novel target, COL6A3 exon 6 that is expressed in the tumor stroma of a variety of solid cancers.

         
TCR Bispecifics Programs

  • IMA401 – Immatics presented preclinical proof-of-concept data from its lead TCER® program, IMA401, at the European Antibody Congress 2020 in November. IMA401 is an antibody-like, “off-the-shelf” biologic directed against a high-density peptide target derived from MAGEA4/8. Submission of a CTA for IMA401 remains on track by the end of 2021.
     
  • IMA402 – Immatics plans to announce preclinical proof-of-concept data for its second TCER® program, IMA402 in Q2 2021. GMP process development activities are targeted to begin at the same time to advance this program towards the Investigational New Drug (IND) stage and clinical development.

Corporate Developments


Scientific Advisory Board Update

  • Immatics has established a new Scientific Advisory Board (SAB) comprised of several leaders and scientific pioneers in immuno-oncology, adoptive cell therapies, clinical oncology and cancer biology. The members of the new SAB include Gwendolyn Binder, Dirk Busch, Christoph Huber, Patrick Hwu, Roland Kontermann, Crystal Mackall, Hidde Ploegh, Hans-Georg Rammensee, and Cassian Yee. Patrick Hwu and Crystal Mackall will co-chair the SAB. Additional information about the members can be found on the Immatics website.

 


Amendment to Resale Registration Statement

  • In connection with the filing of the Annual Report on Form 20-F, Immatics will file an amendment to its existing resale registration statement on Form F-1 to update certain information. This registration statement relates solely to the resale of shares by certain stockholders, and the filing of the amendment is not necessarily indicative of any sales by the holders of their shares. No shares will be issued or sold by Immatics pursuant to the registration statement.

Full Year 2020 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €232.0 million ($284.7 million1) as of December 31, 2020 compared to €119.4 million ($146.5 million1) as of December 31, 2019. The increase is mainly the result of the business combination with ARYA Sciences Acquisition Corporation completed in July 2020 (ARYA merger) and the concurrent PIPE Financing.
             
Revenue: Total revenue, consisting of revenue from collaboration agreements, was €31.3 million ($38.4 million1) for the year ended December 31, 2020, compared to €18.4 million ($22.6 million1) for the year ended December 31, 2019.

Research and Development Expenses: R&D expenses were €67.1 million ($82.3 million1) for the year ended December 31, 2020, compared to €40.1 million ($49.2 million1) for the year ended December 31, 2019. The increase is mainly due to an increase in preclinical and clinical development expenses and an increase in share-based compensation (€14.5 million; $17.8 million1 for the year ended December 31, 2020 compared to €1.6 million; $1.9 million for the year ended December 31, 2019).
             
General and Administrative Expenses: G&A expenses were €34.2 million ($42.0 million1) for the year ended December 31, 2020, compared to €11.8 million ($14.5 million1) for the year ended December 31, 2019. The increase is mainly due to an increase in share-based compensation (€10.9 million; $13.4 million1 for the year ended December 31, 2020 compared to €0.5 million; $0.6 million for the year ended December 31, 2019) as well as one-time transaction costs of the NASDAQ listing in connection with the ARYA merger in July.
             
Net Loss: Net loss was €229.6 million ($281.7 million1) for the year ended December 31, 2020, compared to €32.5 million ($39.9 million1) for the year ended December 31, 2019, of which €152.8 million ($187.5 million1) resulted from a one-time, non-cash expense in connection with the ARYA merger. The main part of this €152.8 million ($187.5 million1) non-cash expense resulted from the share price increase between signing and closing of the ARYA merger.

Full financial statements can be found in the Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.

1 All amounts translated using the exchange rate published by the European Central Bank in effect as of December 31, 2020 (1 EUR = 1.2271 USD).

Upcoming Investor Conferences

  • Kempen Life Science – April 28, 2021
  • Bank of America Healthcare Conference – May 11-13, 2021
  • Jefferies Virtual Healthcare Conference – June 1-3, 2021

         
To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.

About Immatics

Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.

Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates you can also follow us on Twitter and LinkedIn.

Forward-Looking Statements

Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics’ future financial or operating performance. For example, statements concerning the timing of product candidates and Immatics’ focus on partnerships to advance its strategy are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in filings with the SEC. Nothing in this presentation should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements.

For more information, please contact:

For Media Inquiries Investor Relations Contact
Jacob Verghese or Stephanie May John Graziano
Trophic Communications Solebury Trout
Phone: +49 89 2388 7731 Phone: +1 646 378 2942

[email protected]

[email protected]

Immatics N.V.  
Anja Heuer Jordan Silverstein
Corporate Communications Head of Strategy
Phone: +49 89 540415-606 Phone: +1 281 810 7545

[email protected]

[email protected]

 


Immatics N.V. and subsidiaries

Condensed Consolidated Statement of Financial Position of Immatics N.V.

 

 

    As of
      December 31, 2020   December 31, 
2019
      (Euros in thousands)
Assets          
Current assets          
Cash and cash equivalents     207,530   103,353
Other financial assets     24,448   16,023
Accounts receivable     1,250   957
Other current assets     5,763   3,667
Total current assets     238,991   124,000
Non-current assets          
Property, plant and equipment     7,868   4,720
Intangible assets     914   1,008
Right-of-use assets     6,149   3,287
Other non-current assets     724   1,262
Total non-current assets     15,655   10,277
Total assets     254,646   134,277
Liabilities and shareholders’ deficit          
Current liabilities          
Provisions     51   50
Accounts payable     10,052   7,082
Deferred revenue     46,600   59,465
Lease liabilities     1,881   1,411
Other current liabilities     2,025   1,288
Total current liabilities     60,609   69,296
Non-current liabilities          
Deferred revenue     85,475   101,909
Lease liabilities     4,306   1,823
Other non-current liabilities       2,084
Total non-current liabilities     89,781   105,816
Shareholders’ equity (deficit)          
Share capital     629   1,164
Share premium     573,339   190,945
Accumulated deficit     (462,253)   (233,194)
Other reserves     (7,459)   (770)
Total equity (deficit) attributable to shareholders of the parent   104,256   (41,855)
Non-controlling interest       1,020
Total shareholders’ equity (deficit)     104,256   (40,835)
Total liabilities and shareholders’ equity (deficit)     254,646   134,277


 

Immatics N.V. and subsidiaries

Condensed Consolidated Statement of Loss of Immatics N.V.

    Year ended December 31,
    2020   2019   2018
    (Euros in thousands, except share and per share data)
Revenue from collaboration agreements   31,253   18,449   3,770
Research and development expenses   (67,085)   (40,091)   (33,971)
General and administrative expenses   (34,186)   (11,756)   (7,666)
Other income   303   385   3,458
Operating result   (69,715)   (33,013)   (34,409)
Financial income   2,949   790   2,215
Financial expenses   (10,063)   (264)   (161)
Share listing expense   (152,787)    
Financial result   (159,901)   526   2,054
Loss before taxes   (229,616)   (32,487)   (32,355)
Taxes on income      
 Net loss   (229,616)   (32,487)   (32,355)
Attributable to:            
Equity holders of the parent   (229,059)   (31,571)   (31,444)
Non-controlling interest   (557)   (916)   (911)
Net loss   (229,616)   (32,487)   (32,355)
Net loss per share – basic and diluted   (4.77)   (0.95)   (0.95)
Weighted average shares outstanding – basic and diluted   48,001,228   33,093,838   33,093,838


 


Immatics N.V. and subsidiaries

Condensed Consolidated Statement of Comprehensive Loss of Immatics N.V.

        Year ended December 31,
  Notes     2020   2019   2018
        (Euros in thousands)
Net Loss       (229,616)   (32,487)   (32,355)
Other comprehensive loss                
Items that may be reclassified subsequently to profit or loss, net of tax          
Currency translation differences from foreign operations       (6,689)   (29)   313
Total comprehensive loss for the period       (236,305)   (32,516)   (32,042)
                 
Attributable to:                
Equity holders of the parent       (235,748)   (31,600)   (31,131)
Non-controlling interest 20      (557)   (916)   (911)
Total comprehensive loss for the period       (236,305)   (32,516)   (32,042)
                 

  

Immatics N.V. and subsidiaries

Condensed Consolidated Statement of Cash Flows of Immatics N.V.

  Year ended December 31,
  2020   2019   2018
  (Euros in thousands)
           
Cash flows from operating activities          
Loss before taxation (229,616)   (32,487)   (32,355)
Adjustments for:          
Interest income (850)   (790)   (507)
Depreciation and amortization 4,424   3,858   2,176
Interest expense 289   170   16
Share listing expense 152,787    
Equity settled share-based payment 22,908   152   118
MD Anderson compensation expense 45   700   1,360
(Decrease) Increase in other liabilities resulting from share appreciation rights (2,036)   1,864   220
Payment related to share-based compensation awards previously classified as equity-settled (4,322)    
Net foreign exchange differences (4,477)   3  
Changes in working capital          
Increase in accounts receivable (294)   (563)   (175)
Increase in other assets (1,600)   (1,497)   5,608
(Increase) decrease in accounts payable and other current liabilities (23,387)   98,937   43,732
Interest received 808   790   507
Interest paid (289)   (170)   (16)
Net cash provided by/(used in) operating activities (85,610)   70,967   20,684
Cash flows from investing activities          
Payments for property, plant and equipment (7,420)   (2,143)   (429)
Cash paid for investments in Other financial assets (82,930)   (20,473)   (13,101)
Cash received from maturity of investments classified in Other financial assets 74,505   17,551  
Payments for intangible assets (104)   (91)   (78)
Proceeds from disposal of property, plant and equipment   97   94
Net cash provided by/(used in) investing activities (15,949)   (5,059)   (13,514)
Cash flows from financing activities          
Proceeds from issuance of shares to equity holders of the parent 217,918     23,648
Transaction cost deducted from equity (7,939)        
Payments for leases (2,096)   (1,862)  
Net cash provided by/(used in) financing activities 207,883   (1,862)   23,648
Net increase in cash and cash equivalents 106,324   64,046   30,818
Cash and cash equivalents at beginning of period 103,353   39,367   8,415
Effects of exchange rate changes on cash and cash equivalents (2,147)   (60)   134
Cash and cash equivalents at end of period 207,530   103,353   39,367
           



 

Immatics N.V. and subsidiaries

Condensed Consolidated Statement of Changes in Shareholders’ equity (deficit) of Immatics N.V.

(Euros in thousands) Notes Share capital Share premium Accumulated deficit Other reserves Total equity attributable to shareholders of the parent Non-controlling interest Total share-holders’ equity (deficit)
Balance as of January 1, 2018   1,164 167,027 (170,179) (1,054) (3,042) 787 (2,255)
Other comprehensive loss   313 313 313
Net loss   (31,444) (31,444) (911) (32,355)
Comprehensive loss for the year   (31,444) 313 (31,131) (911) (32,042)
Equity-settled tandem awards 18 118 118 118
Issuance of ordinary shares 19 23,648 23,648 23,648
MD Anderson compensation expense 20 1,360 1,360
Balance as of December 31, 2018   1,164 190,793 (201,623) (741) (10,407) 1,236 (9,171)
                 
Balance as of January 1, 2019   1,164 190,793 (201,623) (741)      (10,407) 1,236           (9,171)
Other comprehensive loss   (29) (29) (29)
Net loss   (31,571) (31,571) (916) (32,487)
Comprehensive loss for the year   (31,571) (29) (31,600) (916) (32,516)
Equity-settled tandem awards 18 152 152 152
MD Anderson compensation expense 20 700 700
Balance as of December 31, 2019   1,164 190,945 (233,194) (770)      (41,855) 1,020    (40,835)
                 
Balance as of January 1, 2020   1,164  190,945  (233,194)      (770)      (41,855)     1,020   (40,835)
Other comprehensive loss                 –   (6,689) (6,689)                      – (6,689)  
Net loss   (229,059) (229,059) (557) (229,616)
Comprehensive loss for the year   (229,059) (6,689) (235,748) (557) (236,305)
Reorganization 3,19 (833) 833
Issue of share capital                
MD Anderson Share Exchange 3,19 7 501 508  (508)               –
PIPE Financing, net of transaction costs 3, 19 104 89,973 90,077         90,077
ARYA Merger, net of transaction costs 3,19, 17 180 272,508 272,688 272,688
SAR conversion   18 7 (7)
Total issuance of share capital   298 362,975 363,273 (508) 362,765
Equity-settled share-based compensation 18 22,908 22,908 22,908
Payment related to share-based compensation awards previously classified as equity-settled 18 (4,322) (4,322) (4,322)
MD Anderson compensation expense 20 45 45
Balance as of December 31, 2020   629 573,339 (462,253) (7,459) 104,256 104,256


 

 



 

Attachment



Provectus Biopharmaceuticals Receives Notice of Allowance for Adult Solid Tumor Cancer Combination Therapy Patent for PV-10® Immunotherapy from United States Patent and Trademark Office

KNOXVILLE, TN, March 30, 2021 (GLOBE NEWSWIRE) — Provectus (OTCQB: PVCT) today announced that the United States Patent and Trademark Office (USPTO) has allowed US patent (USP) application 16/678,133, which covers the use of intralesional (aka intratumoral) PV-10, an injectable formulation of Provectus’ proprietary small molecule rose bengal disodium (RBD), in concomitant combination with two immune checkpoint inhibitors (e.g., PV-10 + an anti-CTLA-4 agent + an anti-PD-(L)1 agent) for the treatment of adult solid tumor cancers such as melanoma, breast cancer, primary and metastatic liver cancers, prostate cancer, and small cell and non-small cell lung cancer.

The allowed patent application is the fourth continuation of USP 9,107,887, Provectus’ foundational cancer combination therapy patent granted by the USPTO in 2015. It is also related to USP 9,808,524, USP 9,839,688, and USP 10,471,144, which are also continuations. Provectus is the sole assignee on the allowed patent application.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, “This pending new patent further expands and enhances our intralesional oncology drug development program by protecting, in particular, the concomitant combination of PV-10 and the duo of anti-CTLA-4 and anti-PD-1 agents for the treatment of solid tumor cancers beyond melanoma, for which the combination of ipilimumab and nivolumab has been approved. There is emerging evidence of major differences in how the combination of anti-CTLA-4 and anti-PD-1 drugs acts on T cell populations and thus immune response, compared with either monotherapy.”

Mr. Rodrigues added, “Provectus has shown that single-agent PV-10 treatment of melanoma may lead to the maturation of immature T cells into functional ones, and that the anti-tumor activity of these T cells may be enhanced by the blockade of the PD-1 regulatory pathway. The Company’s clinical study of metastatic uveal melanoma is focused on showing that these T cells can be further enhanced, potentially synergistically so, by the blockade of both the CTLA-4 and PD-1 pathways.”

About PV-10

Intralesional (IL) administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death within hours of tumor injection, and induce tumor-specific reactivity in circulating T cells within days.1,2,3 This IL PV-10-induced functional T cell response may be enhanced and boosted in combination with immune checkpoint blockade (CB).4 In CB-refractory advanced cutaneous melanoma, IL PV-10 may restore disease-specific T cell function, which may also be prognostic of clinical response. IL PV-10 has been administered to over 450 patients with cancers of the skin and of the liver. It is administered under visual, tactile or ultrasound guidance to superficial malignancies, and under CT or ultrasound guidance to tumors of the liver.

About Rose Bengal Disodium

RBD is 4,5,6,7-tetrachloro-2′,4′,5′,7′-tetraiodofluorescein disodium, a halogenated xanthene and Provectus’ proprietary lead molecule. Provectus’ current Good Manufacturing Practices (cGMP) RBD is a proprietary pharmaceutical-grade drug substance produced by the Company’s quality-by-design (QbD) manufacturing process to exacting regulatory standards that avoids the formation of uncontrolled impurities currently present in commercial-grade rose bengal. Provectus’ RBD and cGMP RBD manufacturing process are protected by composition of matter and manufacturing patents as well as trade secrets.

An IL formulation (i.e., by direct injection) of cGMP RBD drug substance, cGMP PV-10, is being developed as an autolytic immunotherapy drug product for solid tumor cancers.

IL PV-10 is also undergoing preclinical study for relapsed and refractory pediatric solid tumor cancers, such as neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma.5,6

A topical formulation of cGMP RBD drug substance, PH-10®, is being developed as a clinical-stage immuno-dermatology drug product for inflammatory dermatoses, such as atopic dermatitis and psoriasis. RBD can modulate multiple interleukin and interferon pathways and key cytokine disease drivers.7

Oral formulations of cGMP RBD are undergoing preclinical study for relapsed and refractory pediatric blood cancers, such as acute lymphocytic leukemia and acute myelomonocytic leukemia.8,9

Oral formulations of cGMP RBD are also undergoing preclinical study as prophylactic and therapeutic treatments for high-risk adult solid tumor cancers, such as head and neck, breast, pancreatic, liver, and colorectal cancers.

Different formulations of cGMP RBD are also undergoing preclinical study as potential treatments for multi-drug resistant (MDR) bacteria, such as Gram-negative bacteria.

Topical formulations of cGMP RBD are also undergoing preclinical study as potential treatments for diseases of the eye, such as infectious keratitis

Tumor Cell Lysosomes as the Seminal Cancer Drug Target

Lysosomes are the central organelles for intracellular degradation of biological materials, and nearly all types of eukaryotic cells have them. Discovered by Christian de Duve, MD in 1955, lysosomes are linked to several biological processes, including cell death and immune response. In 1959, de Duve described them as ‘suicide bags’ because their rupture causes cell death and tissue autolysis. He was awarded the Nobel Prize in 1974 for discovering and characterizing lysosomes, which are also linked to each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Building on the Discovery, Exploration, and Characterization of Lysosomes

Cancer cells, particularly advanced cancer cells, are very dependent on effective lysosomal functioning.10 Cancer progression and metastasis are associated with lysosomal compartment changes11,12, which are closely correlated (among other things) with invasive growth, angiogenesis, and drug resistance13.

RBD selectively accumulates in the lysosomes of cancer cells upon contact, disrupting the lysosomes and causing the cells to die. Provectus2,14, external collaborators5, and other researchers15,16,17 have independently shown that RBD triggers each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Cancer Cell Autolytic Death via RBD: RBD-induced autolytic cell death, or death by self-digestion, in Hepa1-6 murine hepatocellular carcinoma (HCC) cells can be viewed in this Provectus video of the process (ethidium homodimer 1 [ED-1] stains DNA, but is excluded from intact nuclei; lysosensor green [LSG] stains intact lysosomes; the video is provided in 30-second frames, with a duration of approximately one hour). Exposure to RBD triggers the disruption of lysosomes, followed by nucleus failure and autolytic cell death. Identical responses have been shown by the Company in HTB-133 human breast carcinoma (which can be viewed in this Provectus video of the process, with a duration of approximately two hours) and H69Ar human multidrug-resistant small cell lung carcinoma. Cancer cell autolytic cell death was reproduced by research collaborators in neuroblastoma cells to show that lysosomes are disrupted upon exposure to RBD.5

Tumor Autolytic Death via RBD: RBD causes acute autolytic destruction of injected tumors (via autolytic cell death), mediating the release of danger-associated molecular pattern molecules (DAMPs) and tumor antigens; release of these signaling factors may initiate an immunologic cascade where local response by the innate immune system may facilitate systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. Mediated immune signaling pathways may include an effect on STING, which plays an important role in innate immunity.9

Orphan Drug Designations (ODDs)

ODD status has been granted to RBD by the U.S. Food and Drug Administration for metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

Intellectual Property

Provectus’ IP includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the process by which cGMP RBD and related halogenated xanthenes are produced, avoiding the formation of previously unknown impurities that exist in commercial-grade rose bengal in uncontrolled amounts. The requirement to control these impurities is in accordance with International Council on Harmonisation (ICH) guidelines for the manufacturing of an injectable pharmaceutical. US patent numbers are 8,530,675, 9,273,022, and 9,422,260, with expirations ranging from 2030 to 2031.

The Company’s IP also includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the combination of RBD and CB (e.g., anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents) for the treatment of a range of solid tumor cancers. US patent numbers are 9,107,887, 9,808,524, 9,839,688, and 10,471,144, with expirations ranging from 2032 to 2035; US patent application numbers include 20200138942 (i.e., 16/678,133).

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on an entirely- and wholly-owned family of small molecules called halogenated xanthenes. Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company’s website at www.provectusbio.com.

References

1. Wachter et al. Functional Imaging of Photosensitizers using Multiphoton Microscopy. Proceedings of SPIE 4620, 143, 2002.

2. Liu et al. Intralesional rose bengal in melanoma elicits tumor immunity via activation of dendritic cells by the release of high mobility group box 1. Oncotarget 7, 37893, 2016.

3. Qin et al. Colon cancer cell treatment with rose bengal generates a protective immune response via immunogenic cell death. Cell Death and Disease 8, e2584, 2017.

4. Liu et al. T cell mediated immunity after combination therapy with intralesional PV-10 and blockade of the PD-1/PD-L1 pathway in a murine melanoma model. PLoS One 13, e0196033, 2018.

5. Swift et al. Potent in vitro and xenograft antitumor activity of a novel agent, PV-10, against relapsed and refractory neuroblastoma. OncoTargets and Therapy 12, 1293, 2019.

6. Swift et al. In vitro and xenograft anti-tumor activity, target modulation and drug synergy studies of PV-10 against refractory pediatric solid tumors. 2018 ASCO Annual Meeting, J Clin Oncol 36, 2018 (suppl; abstr 10557).

7. Krueger et al. Immune Modulation by Topical PH-10 Aqueous Hydrogel (Rose Bengal Disodium) in Psoriasis Lesions. Psoriasis Gene to Clinic, 8th International Congress, Br J Dermatol 177.

8. Swift et al. In Vitro Activity and Target Modulation of PV-10 Against Relapsed and Refractory Pediatric Leukemia. 2018 ASH Annual Meeting, Blood 132, 2018 (suppl; abstr 5207).

9. Thakur et al. Association of heat shock proteins as chaperone for STING: A potential link in a key immune activation mechanism revealed by the novel anti-cancer agent PV-10. 2020 AACR VAM II, (abstr 5393).

10. Piao et al. Targeting the lysosome in cancer. Annals of the New York Academy of Sciences. 2016; 1371(1): 45.

11. Nishimura et al. Malignant Transformation Alters Intracellular Trafficking of Lysosomal Cathespin D in Human Breast Epithelial Cells. Pathology Oncology Research. 1998; 4(4): 283.

12. Gocheva et al. Distinct roles for cysteine cathepsin genes in multistage tumorigenesis. Genes & Development. 2006; 20(5): 543.

13. Fehrenbacher et al. Lysosomes as Targets for Cancer Therapy. Cancer Research. 2005; 65 (8): 2993.

14. Wachter et al. Imaging Photosensitizer Distribution and Pharmacology using Multiphoton Microscopy. Proceedings of SPIE 4622, 112, 2002.

15. Koevary. Selective toxicity of rose Bengal to ovarian cancer cells in vitro. International Journal of Physiology, Pathophysiology and Pharmacology 4(2), 99, 2012.

16. Zamani et al. Rose Bengal suppresses gastric cancer cell proliferation via apoptosis and inhibits nitric oxide formation in macrophages. Journal of Immunotoxicology, 11(4), 367, 2014.

17. Luciana et al. Rose Bengal Acetate photodynamic therapy-induced autophagy. Cancer Biology & Therapy, 10:10, 1048, 2010.

Trademarks

PV-10® and PH-10® are registered trademarks of Provectus, Knoxville, Tennessee, U.S.A.


FORWARD-LOOKING STATEMENTS:

The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.

The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.

Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.

Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the SEC, including those described in


Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020


and


Provectus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2020


.

###

Contact:

Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999



Coupon Fraud May Be More Prevalent than Expected as the Majority of Shoppers have Attempted to Use an Expired Coupon and Succeeded, According to Two New Surveys from Inmar Intelligence

Data reveal that 90 percent of CPG brands are concerned about coupon fraud, yet 56 percent of cashiers override the coupon when it does not scan and give shoppers the discount

Winston-Salem, NC, March 30, 2021 (GLOBE NEWSWIRE) — Inmar Intelligence, a data-driven technology-enabled services company, today released data from two surveys that each aimed to examine the prevalence of coupon fraud. One survey of 1,000 U.S. adults aimed to find common shopper and retailer behaviors that could lead to coupon fraud. The other, which surveyed 300 U.S. adults who work at CPG companies, identified CPG brands’ perceptions of coupon fraud and how they process it internally. Ultimately, the surveys found that coupon fraud is a major concern for 90 percent of CPG brands, yet consumers are still succeeding at misusing coupons.

Shoppers are participating in behaviors that could result in fraudulent activities. 52 percent of shoppers responded saying they have tried to use an expired coupon and 48 percent of shoppers say they have tried to use a coupon for products that do not apply. Further, 63 percent of shoppers said they try to apply multiple offers when purchasing an item. 

Regardless of if the coupon misuse is happening on the shoppers’ side or the retailers’ side, counterfeit coupons and mis-redemptions cost the retail industry $100+ million per year. According to CPG respondents, 64 percent use trade funds to cover deductions of counterfeit coupons (57 percent write it off). But cost goes beyond dollars as 59 percent of CPG respondents spend at least 20 hours per week investigating, processing and accounting for counterfeit coupons.

But, that is beginning to change as major industry players are demanding better accountability from their trading partners. According to Mike Loyson, Brand Director of Value Delivery / Couponing at Procter & Gamble, “Recent industry movements to block counterfeit coupons at point-of-sale are very encouraging.  P&G is committed to these efforts as eliminating fraud benefits shoppers, retailers and marketers alike.”

Inmar Intelligence is working to eradicate this major issue within retail as it recently announced its commitment to ending coupon fraud by 2024. To do so, Inmar Intelligence introduced a holistic promotion fraud mitigation platform, which combines its new point of sale (POS)-integrated technology CNFRM (pronounced confirm), artificial intelligence, data science and analytics to prevent, detect and remediate coupon fraud. The solution is accessible for retailers and manufacturers for free. 

“Coupon fraud and counterfeiting are issues within retail. We have worked for decades to mitigate this risk for all parties involved,” said John Helmle, EVP & President, FinTech at Inmar Intelligence. “Through insights from our two surveys, the retail industry can better calculate the true cost of coupon counterfeiting and determine ways to eradicate it completely. We are committed to our pledge to end counterfeiting of coupons and have developed the tools to do so within three years.  We look forward to the day when the retail industry is not losing millions of dollars to counterfeit activity and can continue to realize the awesome promotional marketing benefits of coupon price promotion.”

For more information about Inmar Intelligence’s holistic promotion fraud solution, please visit https://www.inmar.com/.

About Inmar Intelligence

Commerce Accelerated.™ 

Inmar Intelligence is a leading data and tech-enabled services company. $120 billion dollars of commerce runs through our market-driven platforms which are propelling digital transformation through unified data and workflows to help leading Fortune 5000 companies, emerging brands and health systems drive innovation.

Throughout our 40-year history, we have served retailers, manufacturers, pharmacies, health systems, government and employers as their trusted intermediary in helping them redefine success. For more information about Inmar, please follow us on Twitter, LinkedIn or Facebook, or call (866) 440-6917.



Holly Pavlika
Inmar Intelligence
(336) 770-3596
[email protected]

Black Diamond Group Announces $15 Million Contract in eastern Canada

CALGARY, Alberta, March 30, 2021 (GLOBE NEWSWIRE) — Black Diamond Group Limited (“Black Diamond”, the “Company” or “we”), (TSX:BDI), a leading provider of space rental and workforce accommodation solutions, today announced that its Workforce Solutions segment has been awarded a contract with approximate total value of $15 million over 31 months. The contract includes the transportation, installation, and rental of workforce accommodation assets that will house up to 610 workers in support of a mining project in eastern Canada. Assets are expected to begin mobilizing early in the second quarter of 2021 with rent beginning in Q3/2021.

“Our WFS segment has continued to focus on driving improved utilization, unlocking the significant amount of operating leverage present in the business, and diversifying by end market and geography. With this most recent contract award, our WFS segment has signed contracts totaling over $50 million since the start of 2021 and will have over 2,000 rooms on rent in eastern Canada in the second half of the year,” said Trevor Haynes, CEO of Black Diamond.

About Black Diamond Group

Black Diamond is a specialty rentals and industrial services Company with two operating business units – Modular Space Solutions (MSS) and Workforce Solutions (WFS). We operate in Canada, the United States, and Australia. MSS through its principal brands, BOXX Modular, Britco, Vanguard, Schiavi, and MPA, owns a large rental fleet of modular buildings of various types and sizes. Its network of local branches rent, sell, service, and provide ancillary products and services to a diverse customer base in the construction, industrial, education, financial, and government sectors. WFS through its principal brands, Black Diamond Camps and Black Diamond Energy Services, owns a large rental fleet of modular accommodation assets of all types and sizes and a fleet of liquid and solid containment assets. Its regional operating terminals rent, sell, service, and provide ancillary products and services including turn-key operated camps to a wide array of customers in the resource, infrastructure, construction, disaster recovery, and education sectors. The WFS business unit also includes the Company’s wholly owned subsidiary, LodgeLink, which operates a digital marketplace for business-to-business crew accommodation, travel, and logistics in North America.

Learn more at www.blackdiamondgroup.com.

Investor and Media Inquiries

Jason Zhang at 403-206-4739 or [email protected]

To sign up for news alerts please go to https://www.blackdiamondgroup.com/investor-centre/news-alerts-subscription/.

Cautionary Note Regarding Forward-Looking Statements
Certain information set forth in this news release contains forward-looking statements. Although Black Diamond believes that the expectations reflected in the forward-looking statements contained in this news release, and the assumptions on which such forward-looking statements are made are reasonable, there can be no assurances that such expectations or assumptions will prove to be correct. Readers are cautioned that assumptions used in the preparation of such statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties and other factors, many of which are beyond the control of Black Diamond. These risks include, but are not limited to: the impact of general economic conditions, industry conditions, fluctuation of commodity prices, the impact of the COVID-19 pandemic, the Company’s ability to attract new customers, failure of counterparties to perform on contracts, industry competition, availability of qualified personnel and management, timely and cost effective access to sufficient capital from internal and external sources, political conditions, dependence on suppliers and stock market volatility. The risks outlined above should not be construed as exhaustive. Additional information on these and other factors that could affect Black Diamond’s operations and financial results are included in Black Diamond’s annual information form for the year ended December 31, 2020   and other reports on file with the Canadian Securities Regulatory Authorities which can be accessed on SEDAR. Readers are cautioned not to place undue reliance on these forward-looking statements. Furthermore, the forward-looking statements contained in this news release are made as at the date of this news release and Black Diamond does not undertake any obligation to update or revise any of the forward-looking statements, except as may be required by applicable securities laws.



Atlas Awarded Contract to Provide Construction, Management and Inspection Services to Forsyth County, GA

AUSTIN, Texas, March 30, 2021 (GLOBE NEWSWIRE) — Atlas Technical Consultants, Inc. (Nasdaq: ATCX) (“Atlas” or the “Company”), a leading provider of Environmental (ENV), Testing, Inspection & Certification (TIC), Engineering & Design (E&D), and Program, Construction and Quality Management (PCQM) services for government and commercial clients, announced today it was awarded a $2.4 million contract by Forsyth County, Georgia to perform Construction Management and Inspection services for the widening of State Route (“SR”) 369 and the construction of an interchange at SR 400.

With a $45.1 million construction budget, this locally funded project will widen SR 369 from an existing two-lane roadway from west of SR 9 to slightly east of SR 306 in Forsyth County. The project also includes upgrading an existing at-grade signalized intersection at SR 400 to a grade separated partial cloverleaf interchange, which will be accomplished in partnership with the Georgia Department of Transportation.

The Company has partnered with Forsyth County for more than 20 years and performed program management services during conceptual design, design, construction document, bidding and construction phases.

“We continue to be proud of the decades-long relationship that has resulted in major projects like Pilgrim Mill and Union Hill Road—both significant bridges over Georgia 400,” said L. Joe Boyer, Atlas CEO. “We are committed to continue providing excellent support through our depth of resources and experience.”

Atlas is committed to creating a strong culture of safety and providing a safe and healthy work environment for all employees and others that may work, visit, or enter their facilities or contractor’s job sites. The Company’s policy is to manage and conduct operations and business in a manner that offers maximum protection to all employees and any other person that may be affected by their operations and business. Atlas makes every effort to provide a working environment that is free from any recognized or potential hazards.


About Atlas Technical Consultants


Headquartered in Austin, Texas, Atlas is a leading provider of Environmental (ENV), Testing, Inspection & Certification (TIC), Engineering & Design (E&D), and Program, Construction and Quality Management (PCQM) services. Under the name Atlas Technical Consultants, we offer solutions to public and private sector clients in the transportation, commercial, water, government, education and industrial markets. With approximately 3,300 employees and a nationwide footprint, Atlas provides a broad range of mission-critical technical services, helping clients test, inspect, certify, plan, design and manage a wide variety of projects across diverse end markets. For more information, go to https://www.oneatlas.com.


Contacts
 
   
Media  
Karlene Barron Investors
770-314-5270 512-851-1507
[email protected] 
[email protected]



Longeveron Provides Corporate Update and Reports Fourth Quarter and Full Year 2020 Financial Results

MIAMI, March 30, 2021 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today reported its financial results for the quarter and full year ended December 31, 2020 and provided a business update.

Primary Accomplishments in 2020:

  • Received approval from U.S. Food and Drug Administration (FDA) to proceed with Phase 1 clinical trial for Acute Respiratory Distress Syndrome (ARDS) related to either COVID-19 or Influenza infection. This trial initiated in mid-2020 and continues to enroll subjects.
  • Received a $650,000, two-year Maryland Stem Cell Research Fund TEDCO Grant Award for ARDS COVID-19/Influenza Phase 1 trial.
  • Treated two COVID-19-related ARDS subjects with Lomecel-B infusion under FDA-approved expanded access (“compassionate use”) protocol.
  • Lomecel-B approved for Phase 2 Aging Frailty clinical trial by Japanese Pharmaceutical and Medical Devices Agency (PMDA) through a Clinical Trial Notification (CTN) application filed by Japan’s National Center for Geriatrics & Gerontology.
  • Successfully completed Phase 1 trial in subjects with Alzheimer’s Disease. Preliminary top-line results were included in the Company’s S-1 Registration Statement filed with the SEC in February 2021. Final results will be announced in the second quarter of 2021, and a Phase 2 trial is expected to commence in the second half of 2021.
  • Lomecel-B Phase 2 HLHS program awarded a $4.5M multiyear grant award from the National Heart, Lung and Blood Institute (NHLBI).
  • Revenue increased in 2020 from both grants and clinical trial (Bahamas Registry Trial) revenue sources, compared to 2019.

Highlights from Q1 2021:

  • Completed $29.1 million Initial Public Offering, including partial exercise of over-allotment, and concurrent listing on Nasdaq.
  • Successfully completed 150 subject Phase 2b clinical study of Lomecel-B infusion for Aging Frailty, with top-line trial results anticipated in the third quarter of 2021.
  • Successfully completed Phase 1 clinical study of Lomecel-B intramyocardial injection in Hypoplastic Left Heart Syndrome (HLHS) subjects, with full results expected in the second quarter of 2021, and Phase 2 trial expected to commence in second half of 2021.
  • Granted expanded access (“compassionate use”) approval by the U.S. FDA for the administration of Lomecel-B to a child with HLHS. Lomecel-B was administered peri-operatively via intramyocardial injection, and the child was discharged from the hospital and is currently being followed per protocol.
  • Expanded enrollment criteria for the Phase 1 ARDS “RECOVER” trial to include mild ARDS, in addition to moderate and severe ARDS.
  • Expanded and amended the exclusive license agreement (ELA) related to Lomecel-B technology rights with the University of Miami (UM) and entered into a Cooperative Research and Development Agreement (CRADA) with UM.

“We are proud of the significant progress made throughout 2020 and into 2021, including our successful IPO in February, which has positioned Longeveron with a stronger balance sheet and the ability to continue to advance the diverse Lomecel-B pipeline of trials,” stated Geoff Green, Chief Executive Officer of Longeveron. “The Company was founded with the goal of developing safe and effective “off-the-shelf” cell therapies that could be used to treat chronic aging-related disease, improve health span and potentially extend longevity. In 2020, in conjunction with our funding partner, the Alzheimer’s Association, we completed a Phase 1 Alzheimer’s disease trial. We are extremely pleased with the safety and preliminary efficacy results. We look forward to announcing the final results in the second quarter of 2021 and initiating the planned Phase 2 multidose trial later this year. Additionally, both of our US Aging Frailty Phase 2 trials will have top line efficacy data available in the 3rd quarter of 2021. This will be very exciting year for Longeveron, with several clinical trial and clinical data-driven catalysts on the near horizon.”

Longeveron’s Aging Frailty research program spans 5 clinical programs in 3 different countries, and includes two US randomized, placebo-controlled Phase 2 trials, a sub-study of the effects of Lomecel-B in Aging Frailty subjects with Metabolic Syndrome, a Japanese Phase 2 study pending initiation, and a Treatment Registry Trial in Nassau, The Bahamas.

“The Japanese PMDA has approved a Phase 2 clinical trial of Lomecel-B infusion in Japanese Aging Frailty subjects, which we expect to initiate in 2021. This trial will be led by the National Center for Geriatrics and Gerontology, the Japanese equivalent to the National Institute on Aging in the US. Similar to our US Phase 2b trial, the objective of this trial is to evaluate the ability for Lomecel-B infusion to improve physical mobility and endurance in Aging Frailty subjects 70 to 85 years of age. Japan is a “super-aged” society and preventing and treating frailty is a priority for the nation. With its progressive and favorable regulatory framework for regenerative medicine products, Japan offers several expedited pathways to market, including conditional marketing approval, at the option of Japanese health regulators, after Phase 2, and a hospital-based approval that is a self-pay model known in Japan as the Act on the Safety of Regenerative Medicine, or ASRM route.”

In 2020, despite the fact that travel into The Bahamas was only allowed for approximately 5 months due to COVID-19, the Company’s Treatment Registry Trial participation and revenue exceeded all of 2019. This reflects increased momentum and demand for participation in the Registry, which the Company anticipates will continue as travel begins to return to normal activity.

The Company’s current exception to its focus on chronic aging-related disease is the research program for children born with Hypoplastic Left Heart Syndrome (HLHS), a rare congenital heart defect that affects about 1,000 babies per year. In that program, Lomecel-B is administered via direct injection into the heart during pre-planned standard-of-care reconstructive surgery. In February 2021, the Company announced the completion of a 10 subject Phase 1 safety study, funded in part by a Maryland Stem Cell Research Fund TEDCO grant, and preparation for the Phase 2 randomized, placebo-controlled study are underway. The NHLBI is the funding partner for the Phase 2 study, and it will be conducted through a consortium of leading pediatric cardiac surgeons in the US, led by Dr. Sunjay Kaushal at the Lurie Children’s Hospital in Chicago, Illinois.

The net proceeds from the recent IPO enable the Company to complete current ongoing clinical trials, and to initiate at least 4 additional Phase 2 clinical trials, with 3 of those 4 trials expected to initiate this year: Japan Aging Frailty Phase 2 Trial; multidose Alzheimer’s disease Phase 2 trial, and HLHS Phase 2 trial.


Financial Results:

Fourth Quarter Ended December 31, 2020 and 2019

Revenue: Total revenue, consisting of revenue from grants and clinical trials (from our Bahamas Registry Trial) was $1.2 million for the fourth quarter of 2020, compared to revenue of $1.8 million for the fourth quarter of 2019. This decrease was a result of a decrease in grant revenue of $0.8 million for 2020 as compared to the same period in 2019, which was expected and is a function of the pre-planned timing of release of funds according to the terms of the various grants. Revenue from our Bahamas Registry Trial increased by $0.3 million or 119% for 2020 as compared to the same period in 2019; despite international travel being severely negatively impacted by COVID-19.

R&D Expenses: Research and development expenses were $1.2 million for the fourth quarter of 2020, compared to $0.3 million for the fourth quarter of 2019. The increase was primarily due to an increase in research and development expenses that were not reimbursable by grants.

G&A Expenses: General and administrative expenses were $0.7 million for the fourth quarter of 2020 and 2019, respectively.

Net Loss: Net loss was $1.4 million for the fourth quarter of 2020, compared to $0.5 million for the fourth quarter of 2019.

Years Ended December 31, 2020 and 2019

Revenue: Total revenue, consisting of revenue from grants, clinical trials (from our Bahamas Registry Trial), and contract manufacturing, was $5.6 million for the years ended December 31, 2020, and 2019. Grant revenue was $4.3 million for the year ended December 31, 2020, compared to $4.1 million for the year ended December 31, 2019. Revenue from the Bahamas Registry Trial was $1.3 million for the year ended December 31, 2020, compared to $1.2 million for the year ended December 31, 2019. Contract manufacturing revenue was $0.1 million for the year ended December 31, 2020, compared to $0.3 million for the year ended December 31, 2019. This decrease was primarily due to COVID-19 related decrease in travel, which restricted the business development and marketing of these services.

R&D Expenses: Research and development expenses were $2.7 million for the year ended December 31, 2020, compared to $1.8 million for the year ended December 31, 2019. The increase was primarily due to an increase in research and development expenses that were not reimbursable by grants. We expect that our research and development expenses will increase in the future as we increase our headcount to support increased research and development activities relating to our clinical programs, as well as incur additional expenses related to our clinical trials.

G&A Expenses: General and administrative expenses were $2.7 million for the year ended December 31, 2020, compared to $2.8 million for the year ended December 31, 2019. Expenses remained relatively consistent for 2020 compared to 2019; general and administrative expenses consisted primarily of rent, professional fees, insurance, and paid and accrued compensation costs. We expect that our general and administrative expenses will increase in the future as we increase our headcount to support increased administrative activities relating to our becoming a public company. We also expect to incur additional expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with Nasdaq and SEC requirements; director and officer insurance costs; and investor and public relations costs.

Net Loss: Net loss was $3.7 million for the year ended December 31, 2020, compared to $3.0 million for the year ended December 31, 2019.

Cash: Cash as of December 31, 2020 was $0.8 million, compared to $1.9 million as of December 31, 2019.

Financial Outlook

Our cash in the first quarter of 2021 was increased by the $29.1 million (gross) in funds received from our IPO. As of March 30, 2021, our cash position was $24.5 million. We believe, based on the current operating plan and financial resources, that our existing cash on hand will be sufficient to cover expenses and capital requirements through at least the fourth quarter of 2022.

Conference Call and Webcast

Management will host a conference call today at 8:30 a.m. Eastern Time to discuss its fiscal 2020 financial results and provide a business update.

The conference call will be available via telephone by dialing toll free 1-855-979-6654 for U.S. callers or +44 20-3936-2999 for international callers and using entry code 094408. You may also pre-register for the event. A webcast of the call may be accessed here or on the Company’s website at https://www.longeveron.com/.

An audio replay of the of the call will be available through April 6, 2021 and can be accessed here and by entering the access code: 40245, and will remain online for one year through March 30, 2022. 

About Longeveron Inc

Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company’s lead investigational product is the LOMECEL-B™ cell-based therapy product (“Lomecel-B”), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company’s mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release that are not historical facts are forward-looking statements that reflect management’s current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact:
Crescendo Communications, LLC
Tel: 212-671-1020
Email: [email protected]

Since the corporate conversion to a Delaware “C” corporation occurred on February 11, 2021, as part of the IPO, the Financial Statements presented for December 31, 2020 and 2019 are for a limited liability company (LLC).

LONGEVERON LLC

SELECTED BALANCE SHEET DATA

  As of December 31,
  2020   2019
Cash $ 815,800     $ 1,865,874  
Total assets   9,240,044       10,584,415  
Total liabilities   7,282,977       6,139,373  
Total members’ equity   1,957,067       4,445,042  



LONGEVERON LLC

STATEMENTS OF OPERATIONS

  For the Years Ended December 31,
  2020     2019  
Revenues:          
Grant revenue $ 4,260,605     $ 4,149,044  
Clinical trial revenue   1,313,500       1,199,500  
Contract manufacturing revenue   55,426       290,922  
Total revenues   5,629,531       5,639,466  
Costs of revenues   3,803,261       3,885,390  
Gross profit   1,826,270       1,754,076  
           
Operating expenses:          
General and administrative   2,731,174       2,774,953  
Research and development   2,674,370       1,791,842  
Selling and marketing   199,003       185,387  
Total operating expenses   5,604,547       4,752,182  
           
Loss from operations   (3,778,277 )     (2,998,106 )
           
Other income   57,469       38,229  
           
Net loss $ (3,720,808 )   $ (2,959,877 )

Source: Longeveron, Inc.



Three in Four Canadian Drivers Who Drive Distracted Believe It’s OK to Do so, RATESDOTCA’s 3rd Annual National Survey Reveals

TORONTO, March 30, 2021 (GLOBE NEWSWIRE) — A recent survey from RATESDOTCA reveals that 74 per cent of drivers who report engaging in certain distracted driving behaviours consider them safe practices behind the wheel. Four in ten passengers who noticed their driver engaging in distracted driving did not ask them to stop. That is despite eight in ten passengers saying they are somewhat or very uncomfortable when witnessing their driver texting or calling (up from 76 per cent in 2020 and 75 per cent in 2019). The findings are disconcerting when compared to results from previous years, which show a rising number of respondents (47 per cent in 2021 vs. 40 per cent in 2020) believe distracted driving is the leading cause of motor vehicular traffic deaths compared to 34 per cent who said impaired driving was the leading cause.

“As troubling as it is to discover that a large number of Canadians admit to engaging in distracted driving behaviours, what’s alarming is that they believe these actions are safe. Almost half of Canadians think distracted driving is the leading cause of motor vehicle deaths, and yet surprisingly they are continuing to drive distracted,” said Jameson Berkow, Managing Editor, RATESDOTCA.

According to the survey, Canadians admit to engaging in these distracted behaviours when driving:

  • Texting or instant message on a hand-held device with 13 per cent overall, with Alberta drivers reporting the highest rate of this behaviour at 19 per cent and British Columbia having the lowest rate at 7 per cent.
  • Eating or drinking coffee/water with 79 per cent overall claiming to engage in this behaviour, and 78 per cent of drivers who do this considering this safe.
  • Reaching for an object is claimed by 56 per cent of drivers, with those aged 65 years and older at 41 per cent likely to do this compared to an average of 57 per cent from other age groups.
  • Using navigational apps on an unmounted hand-held device at 40 per cent overall and 68 per cent of drivers who do this consider this behaviour safe.
  • Making phone calls on a hand-held device at 25 per cent overall, with Quebec drivers at the highest rate at 36 per cent, followed by 23 per cent in Ontario, and Manitoba/Saskatchewan drivers coming in the lowest at 12 per cent likely to do this.
  • Watching a video on a hand-held device with 3 per cent overall and 57 per cent of drivers who do this considers it a safe practice.

Disturbingly, one in ten drivers (13 per cent) claim they would object if a passenger asked them to stop the distracted driving behaviour.

“Distracted driving can lead to injury and death, and even if nobody gets hurt it can still lead to serious financial consequences in terms of fines and paying more for car insurance, with a range of 15-25 per cent increase,” said Berkow. “Drivers need to be reminded that they alone are responsible for the safe handling of several thousand pounds of fast-moving metal and for the sake of making a phone call or checking a notification, the consequences could be tragic.

RATESDOTCA recommends the following tips for drivers and passengers to reduce the threat of distracted driving:

  • Become familiar with what constitutes distracted driving – it may surprise many.
  • Set your mobile phone to “airplane mode” or put it out of sight so you are not disturbed by it while driving. Traffic lights are not the time to check messages – you are still operating the vehicle, so put the phone away.
  • Make a plan in advance to stop safely on your route to check and respond to email, text or phone calls: stick to the plan.
  • As a passenger, make it your responsibility to speak up and ask the driver to stop the distracted driving behaviour and concentrate on driving. Suggest that you are not in any hurry and ask them to pull over and then use their device.
  • Set your vehicle’s radio or dashboard infotainment system before you shift into drive.
  • Snack or enjoy a cup of coffee in advance of your drive. Or do this while parked only.

To review the full findings, visit RATESDOTCA.

About the survey

The Third Annual Distracted Driving survey was conducted by Forum Research between March 10 and 12, 2021 and polled 1001 respondents across Canada. The sample’s age ranged from 18 to 65+ years old. The margin of error for this study is +/-2.5%, 19 times out of 20. To participate in the survey, respondents were required to be over 18 years old and have a driver’s licence. Survey questions were presented via telephone and respondents provided answers through the touchpad of their mobile device or home phone.  

About RATESDOTCA

RATESDOTCA is Canada’s leading rate comparison website that offers a quick and simple digital experience to compare the widest selection of insurance and money products in the market. Get a better rate on car, home, and travel insurance, mortgage, and credit cards all in one location. RATESDOTCA aims to help Canadians make better insurance and money decisions so they can save time and money to spend on what really matters to them. @RATESDOTCA

RATESDOTCA
360 Adelaide Street West, Suite 100
Toronto, Ontario
M5V 1R7
Canada
+1 844-726-0907

For more information or to arrange an interview, please contact:

Alex Jones, Proof Strategies Inc. for RATESDOTCA
[email protected]
(416) 969-2734

Karishma Singh, Proof Strategies Inc. for RATESDOTCA
[email protected]
(416) 969-2769

https://www.globenewswire.com/NewsRoom/AttachmentNg/580fe0b8-c938-454d-a826-459dbe979f80