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8-K - 8-K Q4'2020 - Annexon, Inc.annx-8k_20210325.htm

Exhibit 99.1

 

 

Annexon Biosciences Reports Fourth Quarter and Full-Year 2020 Financial Results

with Recent Business Highlights

 

SOUTH SAN FRANCISCO, Calif., March 25, 2021 – Today Annexon, Inc.  (“Annexon”) (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye, announced fourth quarter and full-year 2020 financial results and business highlights.

 

Recent Business Highlights

 

Annexon continues to make strong progress in advancing its broad and deep pipeline and clinical programs across a  range of potential indications.  Recent highlights include:

 

 

ANX005 in Guillain-Barré Syndrome (GBS).  In March 2021, the company completed evaluation of its drug-drug interaction (DDI) study of ANX005 co-administered with Intravenous Immunoglobulin (IVIg) in 14 patients with GBS.  The DDI study was conducted to evaluate the safety and tolerability of ANX005 and IVIg co-administration in GBS patients, and measured pharmacokinetics (PK) and pharmacodynamics (PD) of ANX005 when administered in combination with IVIg.  IVIg, though not FDA-approved in the United States for GBS, is currently the standard of care for GBS.  Initial results from the DDI study included:

 

 

o

Co-administration of IVIg-ANX005 was well-tolerated.

 

o

Co-administration of IVIg-ANX005 achieved full C1q target engagement, and C1q suppression was maintained within the targeted range.

 

o

The open-label DDI study was not placebo-controlled or powered for statistical significance on efficacy measures.  A number of key GBS outcome measures were recorded from baseline, and early improvement was observed in GBS patients, including increased muscle strength, decreased neurofilament light chain (NfL) and improved GBS disability score.

 

Full results from the DDI study are expected to be submitted to a peer-reviewed forum in 2021.  A placebo-controlled Phase 2/3 trial is ongoing to evaluate the efficacy of ANX005 monotherapy in improving disability in GBS patients.  Data from the Phase 2/3 trial is anticipated in 2023.

 

 

ANX007 in Geographic Atrophy (GA). In February 2021, the company initiated a Phase 2 trial evaluating the efficacy of ANX007 in reducing the area of GA as evaluated by fundus autofluorescence (FAF) in patients with GA, which includes monthly and every other month dosing of ANX007.  Data from this trial is anticipated in 2023.

 

 

In February 2021, Annexon appointed William H. Carson, M.D. to the Board of Directors.  Concurrent with Dr. Carson’s appointment, Thomas G. Wiggans was appointed as Annexon’s chairman.

 

“We continue to make progress against our vision of building a leading, multi-faceted complement therapeutics company with an innovative portfolio for a broad range of autoimmune, neurodegenerative and ophthalmic diseases,” said Douglas Love, Esq., president and chief executive officer of Annexon.  “The DDI data gives us further confidence in ANX005.  We are rapidly advancing multiple Phase 2 clinical programs across a diverse set of potential indications, and accelerating development of a number of innovative, next generation product candidates.  This clinical momentum coupled with our strong capital position positions us well to drive value in 2021 and beyond.”

 

 


 

Fourth Quarter and Full-Year 2020 Financial Results

 

 

Cash and cash equivalents and short-term investments:  Cash and cash equivalents and short-term investments were $351.2 million as of December 31, 2020.

 

 

Research and development (R&D) expenses:  R&D expenses were $18.0 million for the quarter ended December 31, 2020 compared to $6.8 million for the quarter ended December 31, 2019. R&D expenses were $49.3 million for the year ended December 31, 2020 compared to $24.5 million for the year ended December 31, 2019.

 

 

General and administrative (G&A) expenses:  G&A expenses were $5.2 million for the quarter ended December 31, 2020 compared to $2.3 million for the quarter ended December 31, 2019. G&A expenses were $14.2 million for the year ended December 31, 2020 compared to $8.0 million for the year ended December 31, 2019.

 

 

Net loss:  Net loss was $23.2 million for the quarter ended December 31, 2020 compared to $8.9 million for the quarter ended December 31, 2019. Net loss was $63.4 million for the year ended December 31, 2020 compared to $37.2 million for the year ended December 31, 2019.

 

About Annexon, Inc.

Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is deploying a disciplined, biomarker-driven strategy designed to select indications, identify patients and to measure target engagement and response to treatment with its drug candidates. For more information, visit www.annexonbio.com.

 

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology.  All statements other than statements of historical facts contained in this press release are forward-looking statements.  These forward-looking statements include, but are not limited to, statements about: advancement of the company’s clinical and preclinical programs; timing of data from clinical trials and submission of data to peer-reviewed forums; confidence in the company’s product candidates; the company’s ability to drive value in 2021 and beyond; and the implementation of the company’s business model and strategic plans for its business and product candidates, including potential treatment indications and additional indications that the company may pursue.  Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates; the effects of COVID-19 or other public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates.  These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release.  Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

 


 

Investor Contacts:
Jennifer Lew, Chief Financial Officer

Annexon Biosciences

jlew@annexonbio.com

 

Sara Michelmore

smichelmore@macbiocom.com

 

Media Contacts:
Miriam Mason

Annexon Biosciences

mmason@annexonbio.com

 

Caroline Rufo, Ph.D.

crufo@macbiocom.com

 

 

 

 


 

ANNEXON, INC.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended

December 31,

 

 

Year Ended

December 31,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

 

(unaudited)

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (1)

 

$

17,992

 

 

$

6,795

 

 

$

49,271

 

 

$

24,524

 

General and administrative (1)

 

 

5,199

 

 

 

2,334

 

 

 

14,198

 

 

 

7,994

 

Total operating expenses

 

 

23,191

 

 

 

9,129

 

 

 

63,469

 

 

 

32,518

 

Loss from operations

 

 

(23,191

)

 

 

(9,129

)

 

 

(63,469

)

 

 

(32,518

)

Loss on remeasurement of redeemable convertible preferred stock

   liability

 

 

 

 

 

 

 

 

 

 

 

(5,670

)

Other (expense) income, net

 

 

(7

)

 

 

188

 

 

 

57

 

 

 

1,009

 

Net loss before taxes

 

 

(23,198

)

 

 

(8,941

)

 

 

(63,412

)

 

 

(37,179

)

Provision for income taxes

 

 

(5

)

 

 

1

 

 

 

 

 

 

4

 

Net loss

 

 

(23,193

)

 

 

(8,942

)

 

 

(63,412

)

 

 

(37,183

)

Accretion on redeemable convertible preferred stock

 

 

 

 

 

(280

)

 

 

(705

)

 

 

(1,095

)

Deemed dividend – beneficial conversion feature on redeemable

   convertible preferred stock

 

 

 

 

 

 

 

 

(6,219

)

 

 

 

Net loss attributable to common stockholders

 

$

(23,193

)

 

$

(9,222

)

 

$

(70,336

)

 

$

(38,278

)

Net loss per share attributable to common stockholders, basic and

   diluted

 

$

(0.61

)

 

$

(21.26

)

 

$

(4.15

)

 

$

(88.30

)

Weighted-average shares used in computing net loss per share

   attributable to common stockholders, basic and diluted

 

 

38,157,618

 

 

 

433,749

 

 

 

16,962,398

 

 

 

433,493

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) Includes the following stock-based compensation expense:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

990

 

 

 

230

 

 

 

2,274

 

 

 

713

 

General and administrative

 

 

1,001

 

 

 

294

 

 

 

2,614

 

 

 

1,324

 

 

 

 


 

ANNEXON, INC.

Condensed Consolidated Balance Sheets

(in thousands)

 

 

 

December 31,

2020

 

 

December 31,

2019

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

268,565

 

 

$

43,931

 

Short-term investments

 

 

82,641

 

 

 

 

Prepaid expenses and other current assets

 

 

2,805

 

 

 

1,475

 

Total current assets

 

 

354,011

 

 

 

45,406

 

Property and equipment

 

 

1,935

 

 

 

2,138

 

Other long-term assets

 

 

 

 

 

2,354

 

Total assets

 

$

355,946

 

 

$

49,898

 

Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity

   (Deficit)

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,734

 

 

$

2,371

 

Accrued liabilities

 

 

6,497

 

 

 

2,194

 

Deferred rent, current

 

 

391

 

 

 

366

 

Total current liabilities

 

 

10,622

 

 

 

4,931

 

Deferred rent

 

 

1,046

 

 

 

1,437

 

Total liabilities

 

 

11,668

 

 

 

6,368

 

Redeemable convertible preferred stock

 

 

 

 

 

143,984

 

Stockholders’ Equity (Deficit):

 

 

 

 

 

 

 

 

Preferred stock

 

 

 

 

 

 

Common stock

 

 

38

 

 

 

4

 

Additional paid-in capital

 

 

510,309

 

 

 

2,202

 

Accumulated other comprehensive loss

 

 

(77

)

 

 

(80

)

Accumulated deficit

 

 

(165,992

)

 

 

(102,580

)

Total stockholders’ equity (deficit)

 

 

344,278

 

 

 

(100,454

)

Total liabilities, redeemable convertible preferred stock and stockholders’

   equity (deficit)

 

$

355,946

 

 

$

49,898