Scandion Oncology — Proof-of-concept data elusive

Scandion Oncology (OMX: SCOL)

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Research: Healthcare

Scandion Oncology — Proof-of-concept data elusive

Top-line results from part 2 of the Phase II CORIST trial in metastatic colorectal cancer (mCRC) were disappointing for Scandion, as the SCO-101/FOLFIRI combination failed to reach the 30% tumour reduction threshold. Despite this, SCO-101 did show indications of efficacy and the company intends to begin enrolment for CORIST part 3 in Q322, which will investigate a new dosing regimen in a larger patient population to fully evaluate SCO-101’s utility. We continue to estimate a cash runway for the company into FY24; however, as proof-of-concept data have been elusive so far, we expect the company will need to raise capital by end-2023/early FY24 to continue clinical development. Considering CORIST part 2 results, we have reduced our valuation of Scandion Oncology to SEK279.0m or SEK6.9 per share, from SEK609.5m or SEK15.0 per share previously.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Scandion Oncology

Proof-of-concept data elusive

Clinical trial update

Pharma and biotech

5 October 2022

Price

SEK2.08

Market cap

SEK85m

SEK11.1:US$; SEK1.46:DKK

Net cash (DKKm) at end-Q222
(pre-July rights issue)

72.7

Shares in issue

40.7m

Free float

74%

Code

SCOL

Primary exchange

Nasdaq First North Growth Market

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(67.9)

(72.9)

(87.3)

Rel (local)

(66.8)

(72.8)

(84.1)

52-week high/low

SEK19.0

SEK2.1

Business description

Scandion Oncology is a biotechnology company focused on the development of add-on therapies to reverse chemotherapy resistance in oncology. The company’s lead asset, SCO-101, is in Phase II trials for mCRC and Phase Ib trials for pancreatic cancer.

Next events

PANTAX top-line data

Q123

CORIST part 3 top-line data

Q323

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Harry Shrives

+44 (0)20 3077 5700

Scandion Oncology is a research client of Edison Investment Research Limited

Top-line results from part 2 of the Phase II CORIST trial in metastatic colorectal cancer (mCRC) were disappointing for Scandion, as the SCO-101/FOLFIRI combination failed to reach the 30% tumour reduction threshold. Despite this, SCO-101 did show indications of efficacy and the company intends to begin enrolment for CORIST part 3 in Q322, which will investigate a new dosing regimen in a larger patient population to fully evaluate SCO-101’s utility. We continue to estimate a cash runway for the company into FY24; however, as proof-of-concept data have been elusive so far, we expect the company will need to raise capital by end-2023/early FY24 to continue clinical development. Considering CORIST part 2 results, we have reduced our valuation of Scandion Oncology to SEK279.0m or SEK6.9 per share, from SEK609.5m or SEK15.0 per share previously.

Year end

Revenue (DKKm)

PBT*
(DKKm)

EPS*
(DKK)

DPS
(DKK)

P/E
(x)

Yield
(%)

12/20

1.0

(21.5)

(0.53)

0.0

N/A

N/A

12/21

0.8

(57.2)

(1.61)

0.0

N/A

N/A

12/22e

0.8

(64.9)

(1.66)

0.0

N/A

N/A

12/23e

0.8

(82.4)

(1.89)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

SCO-101 development continues

While clinical proof-of-concept has not yet been demonstrated for SCO-101, management is continuing with its planned clinical development programme. CORIST part 3 will investigate an optimised dosing protocol, which, in our view, may have potential for increased efficacy (to be assessed in part 4). Additionally, we see the continued demonstration of SCO-101’s safety and tolerability as encouraging support for higher dosing regimens.

Funding sufficient for part 3, PANTAX

Our estimates for FY22 and FY23 and cash runway to FY24 are unchanged. Our estimated runway will see the company past key readouts from the PANTAX and CORIST (part 3) trials. However, we now expect final CORIST results in mid- to late FY24. We estimate a licensing deal will be found for SCO-101 in 2026 (previously 2024), assuming future clinical results are positive. We estimate the company will need to raise funds (c DKK200m, SEK288m) by end-FY23/early-FY24 to fund development to FY26.

Valuation: SEK279.0m or SEK6.9 per share

We value Scandion Oncology at SEK279.0m or SEK6.9 per share (previously SEK609.5m or SEK15.0 per share). The reduction in our valuation comes as we reduce the probability of success for SCO-101 in mCRC to 10% from 20% and in pancreatic cancer (PC) to 10% from 15%, following CORIST part 2 data. Furthermore, we have adjusted our timeline assumptions and our mCRC patient population estimates to include mutant RAS patients, which is offset by a decreased peak penetration estimate.

CORIST part 2 results

As a reminder, CORIST part 2 was a Phase II trial investigating the efficacy of the SCO-101 in combination with FOLFIRI in mCRC patients harbouring wild-type RAS. The primary endpoint for the study was objective response rate (ORR), defined as complete response and partial response using RECIST v 1.1. Secondary endpoints included progression free survival (PFS), duration-of-response, overall survival (OS) and biomarker analysis. While management has reported that results from part 2 confirmed the safety and tolerability of the SCO-101/FOLFIRI combination in mCRC patients, the trial failed to reach the +30% tumour reduction threshold defined as its primary endpoint. The combination did, however, show evidence of tumour reduction, with prolonged PFS and stable disease.

With the CORIST part 2 results announced, the company will continue with its development timeline for SCO-101 in mCRC. Part 3 of the CORIST study will investigate the safety and tolerability of new, optimised dosing regimens and will inform Part 4, which will investigate the efficacy of the chosen dose. While the results of CORIST part 2 are disappointing for Scandion, we note that patients have continued treatment past the eight-week endpoint and longer-term results will be important in definitively assessing efficacy.

Part 3 to optimised dosing, part 4 to follow

Following top-line date from CORIST part 2, Scandion intends to begin enrolment for CORIST part 3, which will investigate use of the SCO-101/FOLFIRI combination in both mutant and wild-type RAS mCRC patients. As discussed in a brief company update, the trial will enrol up to 36 patients and aims to identify a new dosing schedule (based on pharmacokinetic and pharmacodynamic data from CORIST part 1 and 2), using a dose-escalation [3+3] design. SCO-101 in combination with FOLFIRI will be administered once daily on days one to six and FOLFIRI administered on days two to four of each treatment cycle. The company expects this protocol could be more efficacious than previous regimens. We expect top-line results from part 3 to be reported in Q323. However, this may vary as patient enrolment depends on the observed safety profiles of the new dosing protocols. CORIST part 4, which we expect could begin as soon as Q323 (subject to part 3 enrolment), will then assess the efficacy of the optimised SCO-101/FOLFIRI dosing protocol (n=24) identified in part 3. We expect part 4 will use a similar trial design to that used in part 2 and will run for six months, bringing the earliest potential top-line readout to Q224. Management will provide an update on clinical timelines in Q123.

As evidence of efficacy was observed in CORIST part 2, exploring new dosing regimens of SCO-101/FOLFIRI is an attractive strategy for Scandion, in our view. Additionally, the drug has consistently demonstrated a good safety profile, suggesting higher doses and potentially better efficacy may be tolerated. However, we note that higher doses do not always correlate with increased efficacy and may result in undesirable side effects.

Next catalyst: PANTAX top-line data

We see Phase Ib PANTAX data in PC (expected in H123) as the next key catalyst for Scandion. If the SCO-101/gemcitabine/paclitaxel combination being studied can show signs of efficacy in the PANTAX trial, we expect this will increase confidence in management’s development plans in mCRC. We note, however, that as SCO-101’s proposed mechanism of action in mCRC and PC are the same, there could be potential read-across between the two indications. The trial will primarily assess the safety and tolerability of the SCO-101/gemcitabine/paclitaxel combination; however, secondary endpoints, including ORR, PFS, OS and pharmacokinetic profile, will be a crucial focus, in our view, following the CORIST part 2 data.

Preclinical platform to bolster clinical pipeline

In addition to its clinical development programme, Scandion is conducting preclinical studies for the use of SCO-101 in double combination with chemotherapy and immunotherapy. In a setting (oncology) where many higher lines of treatment are dominated by immune checkpoint inhibitors, we see this as a natural progression for the company. In addition, a second oral efflux pump inhibitor, known as SCO-201, is being evaluated in preclinical studies for the treatment of solid tumours. We anticipate the company will continue to progress assets towards clinical development, thus demonstrating its ability to create value from its drug discovery platform.

Valuation

Considering recent events, we have reduced our valuation of Scandion Oncology to SEK279.0m or SEK6.9 per share from SEK609.5m or SEK15.0 per share. Our valuation is based on a risk-adjusted NPV calculation for SCO-101 in mCRC and PC (applying a 12.5% discount rate) and reflects an estimated net cash position of DKK114m at 30 June 2022 (including estimated net proceeds of the July 2022 SEK75m gross rights issue). The company’s value is reduced as we lower the probability of success for SCO-101 in mCRC to 10% (previously 20%) and in PC to 10% (previously 15%). We believe the failure to reach proof-of-concept in CORIST part 2 could have read-across to potential efficacy readouts in the PANTAX trial, hence our lower probability of success in both indications. Scandion will continue developing SCO-101 in CORIST part 3 and 4, bringing the earliest potential end of the CORIST programme (and Phase II development) to Q224. Therefore, we have delayed our estimated potential launch date for SCO-101 in mCRC to 2028, from 2026 previously. We now assume a potential full licensing deal for SCO-101 is signed in 2026 (previously 2024).

As part 3 and 4 will investigate SCO-101 in both mutant and wild-type RAS patients, we have incorporated this new patient population into our model (previously we only included wild-type patients). However, considering this large increase in patient population (c 50% of mCRC patients harbour mutant RAS) and in light of the recent CORIST part 2 data, we have lowered our peak penetration estimate for SCO-101 to 10% (20% previously) in mCRC and to 10% from 15% in PC. Our remaining valuation assumptions are detailed in our initiation report. A breakdown of our valuation is shown in Exhibit 1.

Exhibit 1: Scandion Oncology valuation

Product

Indication

Launch

Peak

Peak sales ($m)

Value (SEKm)

Probability

rNPV (SEKm)

rNPV/
share (SEK)

SCO-101

mCRC

2028

2032

297.3

1,114.8

10%

51.3

1.3

SCO-101

PC

2029

2033

456.7

1,113.3

10%

60.5

1.5

Pro-forma net cash at 30 June 2022 (estimated after July 2022 raise)

 

 

 

167.1

100%

167.1

4.1

Valuation

 

 

 

2,395.2

279.0

6.9

Source: Edison Investment Research

Financials

As management’s near-term clinical development plan for SCO-101 is largely unchanged by the recent CORIST part 2 data, our FY22 and FY23 financial estimates are unchanged and we continue to estimate that Scandion is sufficiently funded into FY24. As described in our prior note, Scandion had an H122 net cash position of DKK72.7m and in July 2022 it completed a rights issue, raising gross proceeds of c SEK75m. Based on estimated transaction costs of SEK17m (DKK12m), we estimate it resulted in a net cash injection of c SEK58m (DKK41m).

However, we now assume a licensing deal for SCO-101 will be delayed to 2026 (previously 2024), as we expect the company will still need to generate positive randomised data in a Phase II/III trial before a licensing deal is viable. We now estimate the company will need to raise capital by end-2023/early-2024 to fund the longer-term development of SCO-101. Our model suggests c DKK200m (SEK288m) would be sufficient to fund the company’s operations to into FY26 where we anticipate a licensing deal for SCO-101 is agreed.

Our cash runway estimate will see the company past key top-line data readouts from the Phase Ib PANTAX trial (expected H123) and the newly initiated Phase II CORIST part 3. If enrolment for Part 3 is started quickly, then current funds may see the company past part 4. However, if part 3 enrolment is delayed, our estimates indicate Scandion will need additional funds to complete part 4 of the CORIST study and SCO-101’s Phase II development. If timelines are delayed, or clinical data prove positive, this may lead us to revise our cash runway estimate. Our model assumes illustrative debt funding of c DKK200m in early FY24.

Exhibit 2: Financial summary

Accounts: IFRS, year-end: 31 December, DKK’000s

 

 

2020

2021

2022e

2023e

PROFIT & LOSS

 

 

 

 

 

 

Total revenues

 

 

1,003

797

797

797

Cost of sales

 

 

0

0

0

0

Gross profit

 

 

1,003

797

797

797

Total operating expenses

 

 

(24,758)

(56,164)

(65,160)

(83,165)

Research and development expenses

 

 

(21,672)

(47,711)

(52,480)

(70,485)

SG&A

 

 

(3,086)

(8,453)

(12,680)

(12,680)

EBITDA (normalized)

 

 

(23,474)

(54,763)

(63,980)

(82,098)

Operating income (reported)

 

 

(23,755)

(55,367)

(64,363)

(82,368)

Operating margin %

 

 

N/A

N/A

N/A

N/A

Finance income/(expense)

 

 

2,233

(1,846)

(576)

0

Exceptionals and adjustments

 

 

0

0

0

0

Profit before tax (reported)

 

 

(21,522)

(57,213)

(64,939)

(82,368)

Profit before tax (normalised)

 

 

(21,522)

(57,213)

(64,939)

(82,368)

Income tax expense (includes exceptionals)

 

 

4,384

5,508

5,500

5,500

Net income (reported)

 

 

(17,138)

(51,705)

(59,439)

(76,868)

Net income (normalised)

 

 

(17,138)

(51,705)

(59,439)

(76,868)

Basic average number of shares, m

 

 

32.1

32.1

35.9

40.7

Basic EPS (DKK)

 

 

(0.53)

(1.61)

(1.66)

(1.89)

Adjusted EPS (DKK)

 

 

(0.53)

(1.61)

(1.66)

(1.89)

Dividend per share (DKK)

 

 

0.00

0.00

0.00

0.00

BALANCE SHEET

 

 

 

 

 

 

Tangible assets

 

 

136

386

338

418

Intangible assets

 

 

0

0

0

0

Right-of-use assets

 

 

312

1,215

789

789

Other non-current assets

 

 

148

314

290

290

Non-current tax receivables

 

 

0

0

5,500

5,500

Total non-current assets

 

 

596

1,915

6,917

6,997

Cash and equivalents

 

 

5,814

105,710

81,529

3,095

Current tax receivables

 

 

4,384

5,500

5,500

5,500

Trade and other receivables

 

 

1,414

2,018

1,748

1,748

Other current assets

 

 

174,513

1,076

787

787

Total current assets

 

 

186,125

114,304

89,564

11,130

Non-current loans and borrowings

 

 

8

0

0

0

Non-current lease liabilities

 

 

0

500

500

500

Other non-current liabilities

 

 

504

84

1,390

1,390

Total non-current liabilities

 

 

512

584

1,890

1,890

Accounts payable

 

 

26,064

4,580

10,954

10,954

Illustrative debt

 

 

0

0

0

0

Current lease obligations

 

 

316

723

305

305

Other current liabilities

 

 

3,962

5,791

6,810

6,810

Total current liabilities

 

 

30,342

11,094

18,069

18,069

Equity attributable to company

 

 

155,867

104,541

76,522

(1,831)

CASH FLOW STATEMENT

 

 

 

 

 

 

Operating income

 

 

(23,755)

(55,367)

(64,363)

(82,368)

Depreciation and amortisation

 

 

281

604

382

270

Share based payments

 

 

0

0

0

0

Other adjustments

 

 

4,223

2,899

5,303

4,015

Movements in working capital

 

 

2,024

2,066

(5,815)

0

Cash from operations (CFO)

 

 

(17,227)

(49,798)

(64,492)

(78,083)

Capex

 

 

(46)

(318)

(334)

(351)

Acquisitions & disposals net

 

 

0

(167)

25

0

Other investing activities

 

 

0

0

0

0

Cash used in investing activities (CFIA)

 

 

(46)

(485)

(309)

(351)

Capital changes

 

 

7,892

150,690

41,000

0

Debt Changes

 

 

0

0

0

0

Other financing activities

 

 

(226)

(511)

(380)

0

Cash from financing activities (CFF)

 

 

7,666

150,179

40,620

0

Cash and equivalents at beginning of period

 

 

15,421

5,814

105,710

81,529

Increase/(decrease) in cash and equivalents

 

 

(9,607)

99,896

(24,181)

(78,434)

Effect of FX on cash and equivalents

 

 

0

0

0

0

Cash and equivalents at end of period

 

 

5,814

105,710

81,529

3,095

Net (debt)/cash

 

 

5,806

105,710

81,529

3,095

Source: Scandion Oncology, Edison Investment Research


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This report has been commissioned by Scandion Oncology and prepared and issued by Edison, in consideration of a fee payable by Scandion Oncology. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

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United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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OpGen has completed patient sample enrollment in its prospective multicenter trial for the Unyvero urinary tract infection (UTI) panel in the United States, taking the company closer to commercializing another Unyvero test panel, following the lower respiratory tract infection (LRT) and the LRT bronchoalveolar lavage tests in 2018 and 2019, respectively. OpGen reported that more than 1,800 samples have been collected across four sites in the United States as part of the study, exceeding the FDA-recommended 1,500 samples. It expects to conclude data analysis in the next couple of months, staying on track for its planned data readout in H2’22. Positive results will be followed by FDA submission, which we expect in H123. We attribute an 80% probability of approval for the panel, which we will reassess once topline data is released.

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