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Form 8-K

sec.gov

8-K — SpyGlass Pharma, Inc.

Accession: 0001778922-26-000033

Filed: 2026-05-14

Period: 2026-05-14

CIK: 0001778922

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — sgp-20260514.htm (Primary)

EX-99.1 (exhibit991-8kprx051426.htm)

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8-K

8-K (Primary)

Filename: sgp-20260514.htm · Sequence: 1

sgp-20260514

0001778922False00017789222026-05-142026-05-14

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 14, 2026

SpyGlass Pharma, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-43105

83-3044245

(State or other jurisdiction of

incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

27061 Aliso Creek Rd., Suite 100

Aliso Viejo, California 92656

(Address of principal executive offices, including zip code)

(949) 284-6904

(Registrant's telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which

registered

Common Stock, par value $0.00001 per share

SGP

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 2.02. Results of Operations and Financial Condition

On May 14, 2026, SpyGlass Pharma, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2026. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.

The information furnished pursuant to Item 2.02 and in the accompanying Exhibit 99.1 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d)Exhibits.

Exhibit Number

Description

99.1

Press Release of SpyGlass Pharma, Inc., dated May 14, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

1

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

SPYGLASS PHARMA, INC.

By:

/s/ Jean-Frédéric Viret, Ph.D.

Jean-Frédéric Viret, Ph.D.

Date: May 14, 2026

Chief Financial Officer

2

EX-99.1

EX-99.1

Filename: exhibit991-8kprx051426.htm · Sequence: 2

Document

Exhibit 99.1

SpyGlass Pharma Reports First Quarter 2026 Financial Results and Provides Corporate Updates

•Enrollment remains on track in the registrational Phase 3 trials of the Bimatoprost Drug Pad-IOL System (BIM-IOL System), with completion of enrollment expected in 2027.

•Topline 12-month data from the BIM-IOL System Phase 1/2 trial demonstrated elimination of IOP-lowering topical eye drops for 98% of trial participants and 34% mean intraocular pressure (IOP) reduction from baseline, at the intended commercial dose of 78-mcg, and all patients achieving best-corrected distance visual acuity (BCDVA) on par with state-of-the-art monofocal IOLs in the control group at 20/32 or better with a mean BCDVA equivalent to 20/20.

•Bimatoprost-Drug Ring System (BIM-DRS) first-in-human trial is on track to start in the second half of 2026.

•Cash, cash equivalents and short-term investments of $251.0 million on March 31, 2026, are expected to fund planned operations through 2028.

ALISO VIEJO, Calif., May 14, 2026 – SpyGlass Pharma, Inc. (Nasdaq: SGP) (“SpyGlass Pharma” or “Company”), a late-stage biopharmaceutical company, today reported recent business highlights and financial results for the first quarter ended March 31, 2026.

“Following the successful completion of our IPO in February, SpyGlass Pharma is in a strong financial position to complete the development of its sustained release, intraocular delivery of bimatoprost via our BIM-IOL System at the time of cataract surgery in patients with glaucoma. The benefit of potential freedom from daily eye drops for patients is immense, and the BIM-IOL System enables every cataract surgeon to integrate durable, sustained glaucoma care at the time of cataract surgery, with no new surgical techniques required,” stated Patrick Mooney, chief executive officer of SpyGlass Pharma. “We remain highly focused on the enrollment of our registrational Phase 3 trials and the initiation of our first-in-human study of our BIM-DRS, which we expect to occur in the second half of 2026. BIM-DRS has the potential to reach all glaucoma and OHT patients, even if they have already had cataract surgery, and enable lifetime retreatment.”

BIM-IOL System Program Highlights

12-Month Phase 1/2 Data of BIM-IOL System. In March 2026, SpyGlass Pharma announced positive topline results from its Phase 1/2 trial of the BIM-IOL System, to lower IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract. The trial compared BIM-IOL System at the intended commercial dose of 78-mcg (N=51), and 39-mcg (N=23) compared to a physician's choice of commercially available monofocal IOLs from Alcon, Bausch + Lomb or Johnson & Johnson with twice-daily administration of timolol eyedrops as the control group (N=30).

For SpyGlass Pharma’s intended commercial dose of 78-mcg, patients receiving the BIM-IOL System achieved robust clinical improvement:

•A mean, time-matched IOP reduction from baseline of 34%.

•98% of evaluable BIM-IOL patients were free from all topical IOP-lowering medications.

•100% of evaluable patients achieved 20/32 or better best corrected distance visual acuity (BCDVA).

•Mean BCDVA equivalent to 20/20 vision (86 letters), demonstrating a vision performance profile in line with the state-of-the-art IOLs in the control group.

•The BIM-IOL System was well tolerated and exhibited a safety profile comparable to routine cataract surgery, with no serious adverse events observed.

SpyGlass Pharma anticipates presenting additional Phase 1/2 trial results at a future medical meeting.

First Surgeries Completed in Parallel Phase 3 BIM-IOL System Trials. The two registrational Phase 3 trials, SGP-005 and SGP-006, are designed to demonstrate non-inferiority of the BIM-IOL System to a state-of-the-art commercial IOL with twice-daily topical timolol. SpyGlass Pharma continues to expect that both trials will complete enrollment in 2027.

Corporate Highlights

Completion of Initial Public Offering. In February 2026, SpyGlass Pharma completed its initial public offering, including the full exercise of the underwriters’ over-allotment option, raising approximately $172.5 million in gross proceeds and funding planned operations through 2028.

First Quarter 2026 Financial Results

Cash, Cash Equivalents and Short-Term Investments totaled $251.0 million as of March 31, 2026.

Research and Development Expenses were $8.5 million for the first quarter of 2026, compared to $6.1 million for the first quarter of 2025. The increase was primarily due to the hiring of clinical personnel.

General and Administrative Expenses were $6.9 million for the first quarter of 2026, compared to $1.4 million for the first quarter of 2025. The increase was primarily due to higher professional services and personnel.

Net Loss was $13.8 million, or ($0.69) per basic and diluted share, for the first quarter of 2026, compared to $8.8 million, or ($3.96) per basic and diluted share, for same period of 2025.

Upcoming Milestones

•BIM-DRS: Initiation of the FIH trial in the second half of 2026.

•BIM-IOL System: Four-year efficacy and safety follow-up expected in fourth quarter of 2026.

About the Bimatoprost Drug Pad-IOL System

SpyGlass Pharma’s lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), comprising novel, proprietary non-bioerodible drug pads attached to its intraocular lens, was designed to be implanted during routine cataract surgery to reduce elevated intraocular pressure (IOP) in patients who have either open-angle glaucoma (OAG) or ocular hypertension (OHT). The BIM-IOL System is designed to consistently deliver three years of bimatoprost, a prostaglandin analog approved for topical use by the U.S. Food and Drug Administration (FDA) in 2001, for the reduction of elevated IOP in patients with OAG or OHT.

The company initiated two registrational Phase 3 clinical trials of the BIM-IOL System and continues long-term follow-up of patients in the Phase 1/2 study investigating the safety and efficacy of the BIM-IOL System. SpyGlass Pharma plans to work with the FDA to advance the program through completion of Phase III clinical trials, New Drug Application submission, and ultimately to potential FDA approval.

About SpyGlass Pharma

SpyGlass Pharma is a late-stage biopharmaceutical company dedicated to transforming the treatment paradigm for patients living with chronic eye conditions through long-acting, sustained drug delivery of

approved medicines. The Company’s mission is to significantly improve the lives of patients with chronic eye conditions by developing durable drug delivery solutions that can empower patients and surgeons with confidence in long-term disease control and vision preservation.

The SpyGlass Pharma platform, a novel, non-bioerodible drug delivery technology, is designed to be used with various well-established, approved medicines, including bimatoprost and other small molecules, providing flexibility to potentially treat a range of conditions in the front and back of the eye.

The Company was founded in 2019 by Malik Y. Kahook, M.D. and Glenn Sussman to solve the lack of ophthalmic innovations that capitalize on durable treatment options. The SpyGlass Pharma platform was originally developed in the Sue Anschutz-Rodgers Eye Center at the University of Colorado Anschutz School of Medicine

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. All statements in this press release that are not purely historical are forward-looking statements, including, but not limited to, statements regarding: the potential benefits and impact of the BIM-IOL System on patients, anticipated presentation of additional clinical data, including the four-year data from the FIH trial for the BIM-IOL System, the initiation of the FIH trial for BIM-DRS, SpyGlass Pharma’s cash runway, and SpyGlass Pharma’s plans relating to the clinical development of the BIM-IOL System toward commercial launch after FDA approval, including enrollment completion timing. The forward-looking statements contained herein are based upon SpyGlass Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in the Risk Factors section of the Company’s Quarterly Report on Form 10-Q for the three-month period ended March 31, 2026 filed with the Securities and Exchange Commission on or about the date hereof, and in similar disclosures set forth in the other documents that SpyGlass Pharma may file from time to time with the SEC. These forward-looking statements are made as of the date of this press release, and SpyGlass Pharma assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. SpyGlass Pharma’s views in these forward-looking statements should not be relied as representing the Company’s views as of any date subsequent to the date of this press release.

Media Contact:

Nami Surendranath

+1 (402) 507-6757

nsurendranath@dnacommunications.com

Investor Contact:

Ami Bavishi or Nick Colangelo

Gilmartin Group LLC

investors@spyglasspharma.com

SpyGlass Pharma, Inc.

Condensed Statements of Operations

(in thousands, except share and per share data)

(unaudited)

Three Months Ended March 31,

2026 2025

Operating expenses

Research and development $ 8,542  $ 6,052

General and administrative 6,867  1,371

Total operating expenses 15,409  7,423

Loss from operations (15,409) (7,423)

Other income (expense)

Interest income 1,591  126

Change in fair value of redeemable convertible preferred stock tranche liability —  (1,526)

Total other income (expense) 1,591  (1,400)

Loss before income tax (13,818) (8,823)

Income tax provision —  —

Net loss and comprehensive loss $ (13,818) $ (8,823)

Net loss per share

Weighted average common stock outstanding, basic and diluted 19,927,848  2,229,637

Net loss per share of common stock, basic and diluted $ (0.69) $ (3.96)

SpyGlass Pharma, Inc.

Condensed Balance Sheets

(in thousands, except share and per share data)

(unaudited)

As of

March 31, 2026 December 31, 2025

Assets

Current assets

Cash and cash equivalents $ 238,902  $ 96,358

Short-term investments 12,100  11,078

Other receivables 653  431

Prepaid expenses and other current assets 1,707  901

Total current assets 253,362  108,768

Other non-current assets 789  492

Property and equipment, net 2,745  2,339

Deferred offering costs —  2,715

Right-of-use asset 1,490  1,552

Total assets $ 258,386  $ 115,866

Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)

Current liabilities

Accounts payable $ 3,514  $ 2,696

Payroll-related accruals 882  2,182

Other current liabilities 2,271  3,706

Total current liabilities 6,667  8,584

Lease liability, non-current 1,607  1,582

Total liabilities 8,274  10,166

Commitments and contingencies

Redeemable convertible preferred stock, $.00001 par value; 0 shares authorized, issued and outstanding as of March 31, 2026; 116,618,581 shares authorized, 20,341,968 shares issued and outstanding as of December 31, 2025 (aggregate liquidation preference of $0 and $200,878 as of March 31, 2026 and December 31, 2025, respectively) —  204,537

Stockholders' equity (deficit)

Preferred stock, $.00001 par value; 200,000,000 shares authorized, 0 shares issued and outstanding as of March 31, 2026; 0 shares authorized, issued, and outstanding as of December 31, 2025 —  —

Common stock, $.00001 par value; 1,000,000,000 shares authorized, 33,432,555 shares issued and outstanding as of March 31, 2026; 154,383,336 shares authorized; 2,203,620 shares issued and outstanding as of December 31, 2025 —  —

Common stock additional paid-in capital 368,660  5,893

Accumulated deficit (118,548) (104,730)

Total stockholders' equity (deficit) 250,112  (98,837)

Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) $ 258,386  $ 115,866

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