Cereno Scientific publishes interim report for Q3 2021

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The Board and Chief Executive Officer of Cereno Scientific AB here presents the interim report for Q3, 1 July – 30 September, 2021.

Summary of the third quarter, July – September 2021

Cereno Scientific Group

Third quarter (1 July – 30 September 2021)

  • Net Sales were SEK 0 (0)
  • Result after financial items was SEK -3 356 309 (-3 132 513)
  • Earnings per share was SEK -0.05 (-0.08) before dilution and SEK -0.02 (-0.07) after dilution
  • The equity/assets ratio was 89.9% (86.3%)

Parent company

Third quarter (1 July – 30 September 2021)

  • Net sales were SEK 0 (0)
  • Result after financial items was SEK -3 356 528 (-3 139 965)
  • Earnings per share was SEK -0.05 (-0.08) before dilution and SEK -0.02 (-0.07) after dilution
  • The equity/assets ratio was 89.9% (86.3%)

Significant events during the third quarter

  • In August, it was announced that a collaboration agree­ment was entered with global healthcare company Abbott regarding use of its CardioMEMS™ HF System in the Phase II study with Cereno’s drug candidate CS1. The technology will be used to remotely and continuously monitor the pulmonary pressure in the Phase II study evaluating CS1 for the treatment of PAH. The CardioMEMS device allows Cereno to use a small­er-sized patient population for the Phase II study, which is both time and cost efficient.
  • In early September, Cereno obtained patents in 15 European countries for drug candidate CS1 following a completed validation and opposition period. This solid­ifies CS1’s protection by adding to the already granted markets, thus securing patent protection for CS1 in nearly all global key markets.
  • Also in early September, Cereno’s CS585 program was granted the first patent in the US. The CS585 program is currently undergoing a 2-year preclinical development program in collaboration with the University of Michigan with the aim of a successful transition to a Phase I clinical program. The program comprises prostacyclin receptor agonists that have demonstrated potential to significant­ly improve on mechanisms relevant to selected cardio­vascular diseases.
  • Later in September, Cereno Scientific obtained IND ac­ceptance from FDA to start a Phase II study with drug candidate CS1 in PAH. The IND application was submit­ted in August in a collaborative effort with global partner Abbott. The acceptance of the IND allowed Cereno to start the planned Phase II study in patients with PAH at clinical sites in the US in accordance with the submitted study protocol.

Significant events after end of period

  • In early October, Cereno announced that warrants of series TO1 were subscribed to approximately 96.9 per­cent and Cereno received approximately SEK 95.3 mil­lion before issue costs. The warrants were issued during the fourth quarter of 2020 and a total of 33,442,470 warrants were exercised at a subscription price of SEK 2.85 per share.

Letter from the CEO

The third quarter of the year included an important milestone for Cereno as we obtained FDA’s IND acceptance for initiating our Phase II study with CS1 in PAH. In parallel with the hard work that went into preparing and submitting the IND application, we have made great progress with the ongoing development of our two preclinical programs. At the same time, it was satisfying to see that we were able to continue strengthening our intellectual property position with new patents obtained for both the CS1 and CS585 programs. Recently, we also announced that we were able to raise more than SEK 95 million before issue costs through our TO1 warrant program which is a great result that enables us to continue our programs at full speed and look ahead on our future with confidence.

FDA’s IND acceptance for initiating Phase II study with CS1 in PAH in the US

Obtaining IND acceptance from the US FDA for our lead drug candidate CS1 was a great achievement. We have worked intensely together with our partners, including major healthcare company Abbott, to prepare the necessary documentation and steps needed to start the clinical Phase II study in PAH. This includes the development of the study protocol which is the core document for the IND application as all other documents submitted as part of the application relates to different parts of the protocol. Within the stipulated 30 days we received the confirmation that FDA had accepted our IND application. This was expected but still very positive news and a key milestone for the Company. Importantly, we also see the IND acceptance as a great step for patients living with PAH as CS1 has the potential to completely change how these patients are treated. Now, the work continues as we move along with the implementation of the Phase II study. We are looking forward to our continued collaboration with Abbott as the provider of CardioMEMS, a cutting-edge hemodynamic monitoring device. The device provides several benefits including a smaller patient base as we can continuously collect information about the study patients' lung pressure, which leads to time and cost savings. We expect to have topline results for the Phase II study during the second half of 2022.

Progress of ongoing preclinical programs

During the third quarter our two preclinical programs, CS585 and CS014, have been progressing according to the development plans. We are very happy with the collaboration with Dr Mike Holinstat and his research group at the University of Michigan. It is highly rewarding to work with experts of this high caliber in the field of translational research for cardiovascular disease.

Strengthening of patent positions for CS1 and CS585

We continue to pursue the intellectual property protection of our portfolio, and I am glad to see this focus paying off with the recent patent protection expansion for our programs. For CS1 we obtained our first patents in Europe for 15 countries through the European Patent Office (EPO) and when we add that to CS1’s existing patent protection in Australia, Canada, Japan, Russia, and the US we now have coverage across almost all the most important global markets. In addition, it is very positive for us that our preclinical CS585 program was granted the first patent in the key US market. Strengthening our patent position continues to be a priority for us as broad patent protection is generally an important factor when looking at an asset’s commercial potential.

Successful capital raise prioritized for execution of preclinical programs and Phase II study

On the first day of October, we were able to share the news that our issued TO1 warrants were successfully exercised at nearly 97% thus raising more than SEK 95 million before costs. This funding enables us to continue our clinical and non-clinical programs at full speed. It is satisfying to see

the high level of confidence that our shareholders have in us, and we aim to continue building on that by enabling both shareholders and investors to develop a better understanding of our business. To that end, an initial coverage report was recently released by Aktiespararna, in addition to the previous analytical coverage and report initiated by Redeye in August. Aktiespararna, with about 70,000 members, is the world’s largest member organization for private individuals who save in shares and funds. In this effort, I will also have the pleasure of presenting at several investor events during this autumn.

Looking ahead

We recently held our annual strategy meeting. It was great to see the board and management team together again after a long time with only virtual meetings and we enjoyed two days full of great discussions around our way forward. With our highly competent management team and board, leading scientific advisory board, scientific collaborations with Abbott and University of Michigan, three promising programs in the portfolio and a high level of confidence expressed from our shareholders, I remain confident that we as a company are on the right path to deliver on our vision to provide better treatments to patients with common and rare cardiovascular diseases.

November 2021

Sten R. Sörensen
CEO, Cereno Scientific

Financial calendar

Year-end report 2021                                                       9 February 2022

For further information, please contact:
Daniel Brodén, CFO
Tel: +46 768 66 77 87
Email: info@cerenoscientific.com

About Cereno Scientific AB
Cereno Scientific is a clinical stage biotech company within cardiovascular diseases. The lead drug candidate, CS1, is a Phase II candidate in development for the treatment of the rare disease pulmonary arterial hypertension (PAH) and thrombotic indications. CS1 is an HDAC (Histone DeACetylase) inhibitor that acts as an epigenetic modulator with anti-thrombotic, anti-inflammatory, anti-fibrotic and pressure-relieving properties, all relevant for PAH. In addition, Cereno has two promising preclinical development programs, CS014 and CS585, targeted at treating cardiovascular diseases. The company is headquartered in AstraZeneca’s BioVenture Hub, Sweden, and has a US subsidiary Cereno Scientific Inc. based in Kendall Square in Boston, Massachusetts, US. Cereno is listed on the Swedish Spotlight Stock Market (CRNO B). More information on www.cerenoscientific.com.