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THE GENE THERAPY EXPLORER

”Two major milestones were reached during the first quarter. We received positive final data from our preclinical proof-of-concept long-term study and we signed an agreement with British CGT Catapult.” Jan Nilsson, CEO CombiGene AB (publ)

Interim Report January-March 2018 for CombiGene AB (publ)


For many sufferers, there is no help – yet. We hope to change this. We are in the process of developing a world-leading method for treating epilepsy. The potential is enormous, the outlook is good. For very many people. GombiGene – the gene therapy explorer

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Interim Repor t Januar y-March 2018 f or CombiG ene AB (publ)


Interim Report January-March 2018 for CombiGene AB (publ) First quarter January - March 2018 • Nets sales: TSEK 0 (3,000) • Profit from financial items: TSEK -1,999 (249) • Earnings per share SEK -0.12 (0.02) Operations during the first quarter of 2018 • On 12 January 2018 CombiGene and Cell and

Gene Therapy Catapult announced their intention to collaborate on a project of which the aim is to develop a manufacturing process for CombiGene’s candidate drug, CG01. Collaboration is aimed at developing a complete and finalized manufacturing method that will enable CombiGene to proceed with commercial GMP manufacturing and subsequent clinical trials. Final data from CombiGene’s preclinical proofof-concept-study (the long-term study) show that CombiGene’s candidate drug, CG01, has clear antiepileptic effects. The study has demonstrated that CG01 reduces the frequency and duration of epileptic seizures in treatment-responsive animals. A couple of the animals were completely free of seizures after being treated. No side effects have been observed in the study.

Significant events after the end of the reporting period No significant events have occurred after the end of the reporting period.

About CombiGene By combining modern neuroscience with recent advances in gene delivery, CombiGene has developed a method shown to suppress epileptic seizures in preclinical studies. The company’s current focus is on developing this treatment method for the benefit of epilepsy patients, but the platform we will now develop together with Catapult may potentially be used for developing treatments for other diseases. CombiGene, which has offices in Medicon Village in Lund, Sweden, was founded on the basis of the results of research conducted at Lund University and the University of Copenhagen. The company is listed on AktieTorget.

A preference share issue, realized during the period 12 February – 28 February 2018, was subscribed to 22.5 percent, 79 percent of which was subscribed with subscrition rights. The issue raised 2.3 million kronor in issue capital before issuing expenses amounting to MSEK 0.3.

Interim Repor t Januar y-March 2018 f or CombiG ene AB (publ)

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Report of the CEO 2017 was yet another year in which CombiGene delivered according to plan. Both our long-term study and our human expression study were conducted in line with our original intentions and, by the close of 2017, we received positive topline results. The positive results have since been confirmed by final data that were presented during the first quarter of the year. During the quarter CombiGene also realized a preference issue, which was subscribed to 22.5 percent and raised 2.3 million kronor in issue capital before issuing expenses amounting to about MSEK 0.3. Issue of preference shares

Business development

The issue was carried out to strengthen CombiGene’s operating capital, so as to allow us to move to the next phase in the development of CombiGene’s therapy for difficult-to-treat epilepsy in collaboration with British Catapult.

We have begun to intensify our business development efforts. I am pleased to announce that we have strengthened our organization and welcome Karin Agerman in the role of Chief Research & Development Officer. Her solid experience and network are precisely what we need to carry our work forward.

When the board approved the terms of the issue we had already delivered very positive results from our long-term study and we received a very good response from the market. Unfortunately, after a few days there was a general slump in the market and share prices fell dramatically. Since it was not possible to alter the terms of the issue, it could not be fully subscribed. I wish to extend a warm thanks to the shareholders who participated in the issue. I have mentioned this before, but your support is tremendously important for CombiGene’s onward journey, our quest to offer, for the first time, a treatment for patients with drug-resistant epilepsy. In the short term, limited participation in the issue is of little practical significance. CombiGene’s operations will continue according to plan and in line with our ambitions and targets. It is obvious that we must raise more capital earlier than expected, and CombiGene’s board and management are now working to find a solution. Naturally, we have learned a lot from the most recent issue and I am convinced that our next offering will attract great interest from the market.

The epilepsy project – what’s happening now? Two major important milestones were reached during the first quarter. We received positive final data from our preclinical proof-of-concept long-term study and we signed an agreement with British CGT Catapult. Final data from the the long-term study confirmed that CombiGene’s candidate drug, CG01, has clear antiepileptic effects on the frequency and duration of epileptic seizures in treatment-responsive animals. A couple of the animals were completely free of seizures after being treated. No side effects have been observed in the study. In early January CombiGene and Cell and Gene Therapy Catapult announced their intention to collaborate on a project of which the aim is to develop a manufacturing process for our candidate drug, CG01. Collaboration is aimed at developing a complete and finalized manufacturing method that will enable CombiGene to proceed with commercial GMP manufacturing and subsequent clinical trials. /sid. 5/

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Interim Repor t Januar y-March 2018 f or CombiG ene AB (publ)


Several important milestones were reached in 2017. 2018 will be at least as intensive as 2017, but the milestones will not be as evident. Although much energy will invested in the development work we are conducting with CGT Catapult, we do not expect to complete this work this year. Our goal is to complete all stages of development, so that we can begin the first clinical study. I am very proud and pleased to be joining forces with CGT Catapult. They are renowned for leading-edge technologies and ultramodern infrastructure for advanced therapeutic products. We assessed several possible collaborative ventures, but we couldn’t have chosen a better partner. That CGT Catapult has chosen to work with CombiGene attests to their confidence in us and our unique technology. My belief in CombiGene as a company and the future of gene therapy remains steadfast. Jan Nilsson CEO

Interim Repor t Januar y-March 2018 f or CombiG ene AB (publ)

”Final data from the the long-term study confirmed that CombiGene’s candidate drug, CG01, has clear antiepileptic effects on the frequency and duration of epileptic seizures in treatment-responsive animals. A couple of the animals were completely free of seizures after being treated. No side effects have been observed in the study.”

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Financial information

Risks and uncertainty factors

Income and profit/loss The company has had revenue amounting to TSEK 0 (3,000) during the period January-March. Operating profit/loss for the period amounts to TSEK -1,999 (249). The principal costs during the period are mainly attributable to research and development, and fees to the CEO and consultants. Of funds received from Vinnova, the outstanding TSEK 50 has been received during the period. Cash flow and financial position Cash flow for the period January - March amounts to TSEK -314. Cash and bank balances at the close of the period amount to TSEK 4,604. The equity/assets ratio was 85 % at the end of the reporting period. The share The number of shares at the end of the period amounts to 17,197,826, with a quotient value of SEK 0.10. The average number of shares for the period amounts to 16,754,935. All shares are of the same class and have the same voting right. Personnel The average number of employees in the group amounted during the period to 2 (2) person, of which 2 (1) are women. In addition, the CEO acted as a consultant.

A pharmaceutical development company such as CombiGene is exposed to significant operational and financial risk, and many factors can have a negative impact on the probability of commercial success. The risks to which the Company is exposed in its current phase and which must be given careful consideration are the risk that CombiGene’s method is not safe or effective and the risk that the necessary financing cannot be secured. During the quarter no significant changes with respect to these risks or uncertainty factors have arisen. Principles for preparation of the year-end statement CombiGene prepares its financial reports in accordance with the Swedish Annual Accounts Act and BFNAR 2012:1 (K3) Annual Accounts and Consolidated Accounts. The same accounting principles have been applied in this interim report as were applied in the most recent annual report. Review by auditors This report has not been subject to review by the company’s auditors. Future reporting date Interim report 22 August 2018.

Lund, 03 May 2018, CombiGene AB (publ)

Arne Ferstad Chairman

Lars Thunberg Board member

Susana Ayesa Alvarez Board member

Morten Albrechtsen Board member

Peter Nilsson Board member

Jan Nilsson CEO

For further information, please contact: CombiGene AB (publ) Jan Nilsson, VD Tel: +46 (0) 46-275 60 10 E-mail: jan.nilsson@combigene.com

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Interim Repor t Januar y-March 2018 f or CombiG ene AB (publ)


Group income statement in summary Amounts in TSEK Net sales Other operating revenues

2018

2017

2017

Jan - March

Jan - March

Jan - Dec

0

3 000

3 000

50

0

450

-1 772

-2 255

-10 105

-277

-496

-2 303

-1 999

249

-8 958

Operating expenses Other external expenses Personnel expenses Operating profit/loss Net financial income/expense Profit/loss after financial items Tax Net profit/loss for the period

Earnings per share, before dilution Earnings per share, after dilution

-

-

0

-1 999

249

-8 958

-

-

-

-1 999

249

-8 958

-0,12

0,02

-0,54

-0,12

0,02

-0,54

Average number of shares before dilution

16 754 935

13 847 202

15 853 473

Average number of shares after dilution

16 754 935

13 847 202

15 853 473

Total outstanding shares

17 197 826

16 522 230

16 522 230

Interim Repor t Januar y-March 2018 f or CombiG ene AB (publ)

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Group balance sheet in summary Amounts in TSEK

2018

2017

2017

31 March

31 March

31 Dec

ASSETS Fixed assets Intangible assets

1 224

1 224

1 224

Total fixed assets

1 224

1 224

1 224

Current liabilities

1 948

3 888

1 997

Cash and bank balances

4 604

11 915

4 918

Total current assets

6 552

15 803

6 915

TOTAL ASSETS

7 776

17 027

8 139

1 652

1 652

1 652

68

0

0

Current assets

SHAREHOLDERS’ EQUITY AND LIABILITIES Shareholders’ equity Share capital Non-taxable income Other capital contribution

33 029

31 014

31 008

Total shareholders’ equity

-26 148

-17 190

-17 190

Profit/loss for the year

-1 999

249

-8 958

Total shareholders’ equity

6 602

15 725

6 512

Current liabilities

1 174

1 302

1 627

Total liabilities

1 174

1 302

1 627

7 776

17 027

8 139

Liabilities

TOTAL SHAREHOLDERS’ EQUITY AND LIABILITIES

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Interim Repor t Januar y-March 2018 f or CombiG ene AB (publ)


Summary report of changes in the Group’s shareholders’ equity

Share capital

Nonregistered share capital

Other capital contribution

Accumulated profit/loss including profit/loss for the year

Total shareholders’ equity

1 652

0

31 008

-26 148

6 512

68

2 229

Amounts in TSEK

Balance brought forward New share issue Issuing expenses

-208

Net profit/loss for the period Closing balance

2 297

1 652

68

33 029

-208 -1 999

-1 999

-28 147

6 602

Group cash flow statement in summary Amounts in TSEK Cash flow from operating activities

2018

2017

2017

Jan - March

Jan - March

Jan - Dec

-2 403

-2 537

-9 527

Cash flow from investing activities

0

0

0

Cash flow from financing activities

2 089

11 397

11 391

Cash flow for the period Liquid assets at the start of the period Liquid assets at the end of the reporting period

Interim Repor t Januar y-March 2018 f or CombiG ene AB (publ)

-314

8 860

1 863

4 918

3 055

3 055

4 604

11 915

4 918

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Parent Company income statement in summary Amounts in TSEK Net sales Other operating revenues

2018

2017

2017

Jan - March

Jan - March

Jan - Dec

0

3 000

3 000

50

0

450

-1 772

-2 254

-10 086

-277

-496

-2 303

-1 999

250

-8 939

Operating expense Other external expenses Personnel expenses Operating profit/loss Net financial income/expense Income after net financial items Tax Income for the period

10

0

4

-24

-1 999

254

-8 963

-

-

-

-1 999

254

-8 963

Interim Repor t Januar y-March 2018 f or CombiG ene AB (publ)


Parent Company balance sheet in summary Amounts in TSEK

2018

2017

2017

31 March

31 March

31 Dec

1 224

1 224

1 224

ASSETS Fixed assets Intangible assets Financial assets Total fixed assets

166

194

166

1 390

1 418

1 390

Current assets Other receivables

1 948

3 888

1 997

Cash and bank balances

4 423

11 720

4 737

Total current assets

6 371

15 608

6 734

TOTAL ASSETS

7 761

17 026

8 124

1 652

1 652

1 652

68

0

0

SHAREHOLDERS' EQUITY AND LIABILITIES Shareholders’ equity Share capital Non-taxable income Statutory reserve Reserve for development expenses Non-restricted

4

4

4

77

77

77

12 940

13 745

10 919

Share premium reserve Accumulated loss including profit/loss for the year Accumulated loss including profit/loss for the year

-8 139

257

-6 140

Total shareholders’ equity

6 602

15 734

6 512

Liabilities Current liabilities

1 159

1 292

1 612

Total liabilities

1 159

1 292

1 612

TOTAL SHAREHOLDERS’ EQUITY AND LIABILITIES

7 761

17 026

8 124

Interim Repor t Januar y-March 2018 f or CombiG ene AB (publ)

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Summary report of changes in the Parent Company’s shareholders’ equity Amounts in TSEK

Share capital

Nonregistered share capital

Statutory reserve

Reserve for development expenses

Share premium reserve

Accumulated profit/loss including net profit/ loss for the period

1 652

0

4

77

10 919

-6 140

Balance brought forward New share issue

68

Issuing expenses

1 652

68

4

77

6 512

2 229

2 297

-208

-208

Net profit/loss for the period Closing balance

Total shareholders’ equity

12 940

-1 999

-1 999

-8 139

6 602

During 2016 the company has issued 353,760 warrants to the subsidiary CombiGene Personal AB which can be transferred to senior executive in CombiGene AB (publ). During the year the subsidiary has transferred 290,000 warrants and therefore has an additional 63,760 warrants that can be transferred. Every warrant allows the holder to subscribe to one new share in the company at a subscription price of SEK 10.53 and subscriptions may be made during the period as of 7 May 2019 to 21 May 2019. Warrants entail a dilution when the market value of the share exceeds the redemption price of the warrant. There is no dilution effect during the period.

Parent Company cash flow statement in summary Amounts in TSEK Cash flow from operating activities

2018

2017

2017

Jan - March

Jan - March

Jan - Dec

-2 403

-2 537

-9 514

Cash flow from investing activities

0

0

0

Cash flow from financing activities

2 089

11 397

11 391

-314

8 860

1 877

Liquid assets at the start of the period

Cash flow for the period

4 737

2 860

2 860

Liquid assets at the end of the reporting period

4 423

11 720

4 737

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Interim Repor t Januar y-March 2018 f or CombiG ene AB (publ)


Group financial key ratios Amounts in TSEK

2018

2017

2017

Jan - March

Jan - March

Jan - Dec

Financial key ratios Earnings per share, before dilution SEK

-0,12

0,02

-0,54

Earnings per share, after dilution SEK

-0,12

0,02

-0,54

Shareholders’ equity per share, SEK Equity/assets ratio, %

0,38

0,95

0,39

84,90

92,35

80,00

Average number of shares before dilution

16 754 935

13 847 202

15 853 473

Average number of shares after dilution

16 754 935

13 847 202

15 853 473

Total outstanding shares

17 197 826

16 522 230

16 522 230

Share capital development Total shareholders’ equity (SEK)

Change (SEK)

Total number of shares

Change in number of shares

Quotient value (SEK)

Year

Event

1990

Company registration

50 000

50 000

500

500

100,00

1997

Bonus issue

100 000

50 000

1 000

500

100,00

2010

New issue

102 600

2 600

1 026

26

100,00

2013

New issue

143 600

41 000

1 436

410

100,00

2014

Bonus issue

574 400

430 800

5 744

4 308

100,00

2014

New issue

604 400

30 000

6 044

300

100,00

2014

Split 1 000:1

604 400

0

6 044 000

6 037 956

0,10

2014

New issue

884 400

280 000

8 844 000

2 800 000

0,10

2015

New issue

1 134 400

250 000

11 344 000

2 500 000

0,10

2015

New issue

1 138 197

3 797

11 381 970

37 970

0,10

2016

New issue

1 180 159

41 962

11 801 590

419 620

0,10

2017

New issue

1 652 223

472 064

16 522 230

4 720 637

0,10

2018

New issue

1 719 783

67 560

17 197 826

675 596

0,10

At the end of the period

1 719 783

17 197 826

0,10

The new 2018 issue was registered by the Swedish Companies Registration Office on 6 April 2018.

Interim Repor t Januar y-March 2018 f or CombiG ene AB (publ)

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www.combigene.com CombiGene AB (publ)  Medicon Village, SE-223 81 Lund, Sweden  info@combigene.com

CombiGene Interim Report January-March 2018  
CombiGene Interim Report January-March 2018