KALA Kala Pharmaceuticals Inc.

1.85
-0.07  -4%
Previous Close 1.92
Open 1.82
52 Week Low 1.69
52 Week High 9.969
Market Cap $103,710,750
Shares 56,059,865
Float 48,781,503
Enterprise Value $108,292,528
Volume 801,724
Av. Daily Volume 1,536,784
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Drug Pipeline

Drug Stage Notes
EYSUVIS (KPI‑121) 0.25%
Dry eye disease
Approved
Approved
FDA approval announced October 27, 2020.
INVELTYS
Post‑operative inflammation and pain following cataract surgery
Approved
Approved
FDA approval announced August 23, 2018.

Latest News

  1. WATERTOWN, Mass., Nov. 18, 2021 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), today announced that the Company granted non-statutory stock options to new employees as inducement awards outside the Company's 2017 Equity Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

    The Company granted stock options to purchase up to an aggregate of 131,500 shares of Kala Pharmaceuticals common stock to three new employees in connection with the Company's acquisition of Combangio, Inc. on November 15, 2021, including an option to purchase 100,000 shares to Darius Kharabi, who was appointed Chief Business Officer of the Company upon closing of the acquisition. The Company also granted stock options to purchase up to an aggregate…

    WATERTOWN, Mass., Nov. 18, 2021 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), today announced that the Company granted non-statutory stock options to new employees as inducement awards outside the Company's 2017 Equity Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

    The Company granted stock options to purchase up to an aggregate of 131,500 shares of Kala Pharmaceuticals common stock to three new employees in connection with the Company's acquisition of Combangio, Inc. on November 15, 2021, including an option to purchase 100,000 shares to Darius Kharabi, who was appointed Chief Business Officer of the Company upon closing of the acquisition. The Company also granted stock options to purchase up to an aggregate of 4,000 shares of Kala Pharmaceuticals common stock to a new employee that joined the Company unrelated to the acquisition. All of the stock options were granted on November 15, 2021. The grants were approved by the Compensation Committee and were made as an inducement material to each employee entering into employment with Kala Pharmaceuticals in accordance with Nasdaq Listing Rule 5635(c)(4). The option awards have an exercise price of $2.10 per share, the closing price of Kala Pharmaceuticals' common stock on November 15, 2021. The options have a ten-year term and vest over four years, with 25% of the original number of shares vesting on the first anniversary of the applicable employee's new hire date and the remainder vesting in equal monthly installments over the following three years. Vesting of each option is subject to such employee's continued service with Kala Pharmaceuticals through the applicable vesting dates.

    About Kala Pharmaceuticals, Inc.

    Kala is a commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFY® mucus-penetrating particle (MPP) Drug Delivery Technology to two ocular therapies, EYSUVIS® (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of signs and symptoms of dry eye disease and INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% for the treatment of post-operative inflammation and pain following ocular surgery. The Company also has a pipeline of development programs including a clinical-stage secretome product candidate, KPI-012, initially targeting persistent corneal epithelial defects (PCED) and multiple proprietary NCE preclinical development programs targeted to address unmet medical needs, including both front and back of the eye diseases. For more information on Kala, please visit www.kalarx.com.

    Investor Contacts:

    Jill Steier



    781-810-4086

    Hannah Deresiewicz



    212-362-1200



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  2. -- Achieved $3.1 Million in Net Revenue in 3Q 2021 --
    -- EYSUVIS® Prescriptions Increased by 19% Compared to 2Q 2021
    -- Expanding Clinical-Stage Pipeline Through Acquisition of Combangio --
    -- Conference Call and Webcast at 10:30 a.m. ET --

    WATERTOWN, Mass., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.

    "We have made progress toward our goal of providing patients and physicians with a portfolio of innovative medicines and product candidates that can…

    -- Achieved $3.1 Million in Net Revenue in 3Q 2021 --

    -- EYSUVIS® Prescriptions Increased by 19% Compared to 2Q 2021

    -- Expanding Clinical-Stage Pipeline Through Acquisition of Combangio --

    -- Conference Call and Webcast at 10:30 a.m. ET --

    WATERTOWN, Mass., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.

    "We have made progress toward our goal of providing patients and physicians with a portfolio of innovative medicines and product candidates that can better treat diseases of the front and back of the eye," said Mark Iwicki, Chief Executive Officer of Kala. "We continue to receive positive feedback from physicians and patients on EYSUVIS and saw 19% prescription growth in the third quarter compared to the prior quarter. In parallel, we continue to invest in advancing our pipeline and today announced the acquisition of Combangio and its lead product candidate, now known as KPI-012, a novel biologic for the treatment of rare ocular surface diseases. We believe that together with our rTKI and SEGRM programs, KPI-012 will serve as a key foundation for our long-term growth. We look forward to submitting an investigational new drug application to the U.S. Food and Drug Administration for KPI-012 and, subject to regulatory clearance, initiating a Phase 2/3 trial for persistent corneal epithelial defect in the third quarter of 2022."

    Third Quarter and Recent Business Highlights:

    EYSUVIS® (loteprednol etabonate ophthalmic suspension) 0.25%: EYSUVIS became commercially available in January 2021 as the first and only FDA-approved medicine for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. Data from Symphony Health and the EYSUVIS patient hub indicate that 18,537 EYSUVIS prescriptions were filled in the third quarter of 2021, representing quarter-over-quarter growth of 19%. As of the week ended November 5, 2021, 50,862 prescriptions of EYSUVIS, including over 6,652 refill prescriptions, written by more than 5,502 unique prescribers, have been filled since the product launched in early January 2021.

    As of the end of the third quarter of 2021, Kala has secured coverage for more than 99 million commercial lives, which represents approximately 60% of all commercially insured lives. In the third quarter, EYSUVIS added an additional 4.5 million covered lives through health plans and existing contracts with Express Scripts and OptumRx. Kala continues to engage in contract discussions with other commercial health plans and expects to further expand formulary coverage in the coming months. In addition, as of the end of the third quarter of 2021, EYSUVIS achieved 10% Medicare Part D coverage, an increase of 3% for the quarter and total coverage for EYSUVIS is 4.5 million Medicare Part D lives.

    INVELTYS® (loteprednol etabonate ophthalmic suspension) 1%: 37,410 INVELTYS prescriptions were reported by Symphony Health in the third quarter of 2021, compared to 41,103 prescriptions reported in the second quarter of 2021. INVELTYS prescriptions declined in the quarter due to continued weakness in the ocular surgery market from COVID-19 as well as the removal of INVELTYS from the CVS/Caremark formulary coverage list. Kala believes that INVELTYS prescriptions and revenues will return to growth as the number of ocular surgeries return to pre-COVID levels. However, the Company is unable to project the specific timing or quantify the specific potential impact on future revenues given the continued uncertainty around the impact and duration of the COVID-19 pandemic on elective procedures, which includes ocular surgeries.

    Development-Stage Pipeline: In a separate press release issued today, Kala announced the acquisition of Combangio, Inc., a private, clinical-stage company developing a novel investigational secretome therapy, now known as KPI-012, to address the complex wound healing process in persistent corneal epithelial defect (PCED) and other severe ocular diseases driven by impaired corneal healing. KPI-012 is initially in clinical development for the treatment of PCED, a rare disease with an estimated incidence in the U.S. of 100,000 cases per year and 238,000 cases per year in the U.S., E.U. and Japan combined, and has received Orphan Designation for the treatment of PCED by the U.S. Food and Drug Administration (FDA). Kala plans to submit an investigational new drug (IND) application to FDA for KPI-012 and, subject to regulatory clearance, initiate a Phase 2/3 trial of KPI-012 in the third quarter of 2022.

    In addition, Kala continues to progress its development programs targeted to address front and back of the eye diseases. These programs, all of which are new chemical entities (NCEs), include a receptor Tyrosine Kinase Inhibitor candidate (rTKI), KPI-287, and selective glucocorticoid receptor modulators (SEGRMs). KPI-287 is administered via suprachoroidal delivery for the treatment of retinal diseases, including wet age-related macular degeneration (wet AMD). Kala expects to announce preclinical pharmacokinetics and efficacy data in the first quarter of 2022.

    SEGRMs are a novel class of therapies designed to modify the downstream activity of the glucocorticoid receptor to exhibit the anti-inflammatory and immunomodulatory properties of corticosteroids while potentially avoiding the typical safety concerns of steroids. Kala expects to determine a development candidate in the first half of 2022. Kala owns all intellectual property and worldwide rights to its pipeline candidates.

    Financial Results:

    The financial results below contain both GAAP and non-GAAP financial measures. The non-GAAP financial measures exclude stock-based compensation expense, loss on extinguishment of debt, non-cash interest expense and depreciation and amortization. See "Non-GAAP Financial Measures" below; for a full reconciliation of Kala's GAAP to non-GAAP financial measures, please refer to the tables at the end of this press release.

    • Cash Position: As of September 30, 2021, Kala had cash and cash equivalents of $124.5 million, compared to $149.6 million of cash, cash equivalents and short-term investments as of June 30, 2021. This decrease primarily reflects cash used in operations. Cash and cash equivalents as of September 30, 2021 do not reflect the $5 million paid as upfront consideration for the acquisition of Combangio, which was announced in a separate press release this morning. Based on its current plans, including the costs to acquire Combangio and develop KPI-012, Kala anticipates that its cash resources as of September 30, 2021, together with anticipated revenue from EYSUVIS and INVELTYS and certain cost containment measures, will enable it to fund its operations until the second quarter of 2023.

    Third Quarter 2021 Financial Results

    • Net Product Revenues: For the quarter ended September 30, 2021, Kala reported net product revenues of $3.1 million, consisting of $1.83 million of net revenues from EYSUVIS sales and $1.24 million of net revenues from INVELTYS sales, compared to $2.2 million from INVELTYS sales for the same period in 2020.



    • Cost of Product Revenues: For the quarter ended September 30, 2021, cost of product revenues was $0.9 million, compared to $0.7 million for the same period in 2020. Cost of product revenues increased due to units of EYSUVIS sold. Non-GAAP cost of product revenues was $0.9 million for the quarter ended September 30, 2021, compared to $0.7 million for the same period in 2020.



    • SG&A Expenses: For the quarter ended September 30, 2021, selling, general and administrative (SG&A) expenses were $25.3 million, compared to $23.9 million for the same period in 2020. The increase was primarily due to an increase in costs as a result of the launch of EYSUVIS, including expansion of Kala's field sales force. Non-GAAP SG&A expenses were $22.1 million for the quarter ended September 30, 2021, compared to $20.5 million for the same period in 2020.



    • R&D Expenses: For the quarter ended September 30, 2021, research and development (R&D) expenses were $2.9 million, compared to $3.5 million for the same period in 2020. The decrease was primarily due to costs incurred for STRIDE 3, Kala's Phase 3 clinical trial of EYSUVIS as well as other costs related to EYSUVIS that were expensed as research and development, during the third quarter of 2020 which were not incurred during the same period in 2021, partially offset by increased spending on pipeline programs. Non-GAAP R&D expenses were $2.0 million for the quarter ended September 30, 2021, compared to $2.4 million for the same period in 2020.



    • Operating Loss: For the quarter ended September 30, 2021, loss from operations was $26.1 million, compared to $25.8 million for the same period in 2020. Non-GAAP operating loss was $21.9 million for the quarter ended September 30, 2021, compared to $21.4 million for the same period in 2020.



    • Net Loss: For the quarter ended September 30, 2021, net loss was $28.1 million, or $0.43 per share, compared to a net loss of $27.9 million, or $0.50 per share, for the same period in 2020. Non-GAAP net loss was $23.5 million for the quarter ended September 30, 2021, compared to $23.2 million for the same period in 2020. The weighted average number of shares used to calculate net loss per share was 65.1 million for the quarter ended September 30, 2021 and 56.0 million for the quarter ended September 30, 2020.

    Financial Results for the Nine Months ended September 30, 2021

    • Net Product Revenues: For the nine months ended September 30, 2021, Kala reported net product revenues of $9.4 million, consisting of $5.1 million of net revenues from EYSUVIS sales and $4.3 million of net revenues from INVELTYS sales, compared to $4.1 million of net revenue from INVELTYS sales for the same period in 2020.



    • Cost of Product Revenues: For the nine months ended September 30, 2021, cost of product revenues was $2.7 million, compared to $1.8 million for the same period in 2020. The increase was primarily due to units of EYSUVIS sold as well as the increase in total INVELTYS units sold during the nine months ended September 30, 2021, compared to the same period in 2020, partially offset by a reserve for excess INVELTYS inventory of $0.5 million recorded during the nine months ended September 30, 2020, which did not occur during the same period in 2021. Non-GAAP cost of product revenues was $2.5 million for the nine months ended September 30, 2021, compared to $1.7 million for the same period in 2020.



    • SG&A Expenses: For the nine months ended September 30, 2021, selling, general and administrative (SG&A) expenses were $81.0 million, compared to $54.6 million for the same period in 2020. The increase was primarily due to an increase in costs as a result of the launch of EYSUVIS, including expansion of Kala's field sales force and stock-based compensation costs. Non-GAAP SG&A expenses were $70.1 million for the nine months ended September 30, 2021, compared to $47.2 million for the same period in 2020.



    • R&D Expenses: For the nine months ended September 30, 2021, R&D expenses were $9.1 million, compared to $15.0 million for the same period in 2020. The decrease was primarily due to costs incurred for STRIDE 3, Kala's Phase 3 clinical trial of EYSUVIS, during the nine months ended September 30, 2020, which were not incurred during the same period in 2021, partially offset by increased spending on pipeline programs. Non-GAAP R&D expenses were $6.1 million for the nine months ended September 30, 2021, compared to $12.5 million for the same period in 2020.



    • Operating Loss: For the nine months ended September 30, 2021, loss from operations was $83.4 million, compared to $67.2 million for the same period in 2020. Non-GAAP operating loss was $69.3 million for the nine months ended September 30, 2021, compared to $57.3 million for the same period in 2020.



    • Net Loss: For the nine months ended September 30, 2021, net loss was $95.0 million, or $1.49 per share, compared to a net loss of $73.2 million, or $1.44 per share, for the same period in 2020. Non-GAAP net loss was $74.5 million for the nine months ended September 30, 2021, compared to $62.5 million for the same period in 2020. The weighted average number of shares used to calculate net loss per share was 63.8 million for the nine months ended September 30, 2021, and 50.9 million for the nine months ended September 30, 2020.

    Conference Call Information:

    Kala will host a live conference call and webcast today, November 15, 2021 at 10:30 a.m. ET to review its third quarter 2021 financial results, as well as its acquisition of Combangio, which was announced in a separate press release this morning. To access the live conference call, please dial 866-300-4091 (domestic callers) or 703-736-7433 (international callers) five minutes prior to the start of the call and provide the conference ID: 7298039.

    To access the live webcast, which will include a slide presentation, and subsequent archived recording of the call, please visit the "Investor" section on the Kala website at http://kalarx.com.

    Non-GAAP Financial Measures:

    In this press release, the financial results of Kala are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in this press release are stock-based compensation expense, loss on extinguishment of debt, non-cash interest expense and depreciation and amortization. Management believes this non-GAAP information is useful for investors, taken in conjunction with Kala's GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Kala's operating performance. These measures are also used by management to assess the performance of the business. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. For a reconciliation of these non-GAAP financial measures to the most comparable GAAP measures, please refer to the table at the end of this press release.

    About EYSUVIS:

    EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% is approved for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. EYSUVIS utilizes Kala's AMPPLIFY® mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissue of the ocular surface. In preclinical studies, the AMPPLIFY Drug Delivery Technology increased delivery of LE into target ocular tissues more than three-fold compared to an active LE comparator by facilitating penetration through the tear film mucins. EYSUVIS was approved by the FDA on October 26, 2020. Kala believes that EYSUVIS' broad mechanism of action, rapid onset of relief of both signs and symptoms, favorable tolerability and safety profile and the potential to be complementary to existing therapies, offer a differentiated product profile for the short-term treatment of dry eye disease, including the management of dry eye flares.

    EYSUVIS, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. The initial prescription and each renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, as well as defects in visual acuity and fields of vision. Corticosteroids should be used with caution in the presence of glaucoma. Renewal of the medication order should be made by a physician only after examination of the patient and evaluation of the IOP. Use of corticosteroids may result in posterior subcapsular cataract formation. Use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, corticosteroids may mask infection or enhance existing infection. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. The most common adverse drug reaction following the use of EYSUVIS for two weeks was instillation site pain, which was reported in 5% of patients.

    Please see full Prescribing Information at www.eysuvis.com.

    About INVELTYS:

    INVELTYS (loteprednol etabonate ophthalmic suspension) 1% is a twice-a-day corticosteroid for the treatment of post-operative inflammation and pain following ocular surgery. INVELTYS utilizes Kala's proprietary AMPPLIFY mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissues of the eye. In preclinical studies, the AMPPLIFY Drug Delivery Technology increased delivery of LE into target ocular tissues more than three-fold compared to an active LE comparator by facilitating penetration through the tear film mucins. INVELTYS was approved by the FDA on August 22, 2018. Kala believes INVELTYS has a favorable profile for the treatment of inflammation and pain following ocular surgery, due to its twice-a-day dosing regimen.

    INVELTYS, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. A prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored. Use of corticosteroids may result in posterior subcapsular cataract formation. Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. In clinical trials, the most common adverse drug reactions were eye pain (1%) and posterior capsular opacification (1%). These reactions may have been the consequence of the surgical procedure.

    Please see full Prescribing Information at www.inveltys.com.

    About Kala Pharmaceuticals

    Kala is a commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFY® mucus-penetrating particle (MPP) Drug Delivery Technology to two ocular therapies, EYSUVIS® (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of signs and symptoms of dry eye disease and INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% for the treatment of post-operative inflammation and pain following ocular surgery. The Company also has a pipeline of development programs including a clinical-stage secretome product candidate initially targeting persistent corneal epithelial defects (PCED) and multiple proprietary NCE preclinical development programs targeted to address unmet medical needs, including both front and back of the eye diseases. Kala plans to submit an investigational new drug application with the FDA for KPI-012 and, subject to regulatory clearance, commence a Phase 2/3 clinical trial for PCED in the United States in third quarter of 2022. For more information on Kala, please visit www.kalarx.com.

    Forward Looking Statements:

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Any statements in this press release about Kala's future expectations, plans and prospects, including but not limited to statements about Kala's acquisition of Combangio and the other transactions contemplated by the acquisition of Combangio and any other statements about future expectations, prospects, estimates and other matters that are dependent upon future events or developments, including statements related to Kala's expectations with respect to the potential financial impact and benefits of the acquisition of Combangio, expectations with respect to potential advantages of KPI-012, the future development or commercialization of KPI-012, conduct and timelines of clinical trials, the clinical utility of KPI-012 for PCEDs, plans for regulatory filings, the market opportunity for KPI-012 for PCEDs and other indications, plans to pursue research and development of KPI-012 for other indications, expectations regarding the growth in EYSUVIS and INVELTYS prescriptions and revenue over time, estimates regarding anticipated product revenue and planned cost containment measures, Kala's plans to progress its pipeline of preclinical development programs targeted to address front and back of the eye diseases, the sufficiency of Kala's existing cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "likely," "will," "would," "could," "should," "continue," and similar expressions constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the impact of extraordinary external events, such as the current pandemic health event resulting from the novel coronavirus (COVID-19), and their collateral consequences, including disruption of the activities of Kala's sales force and the market for EYSUVIS and INVELTYS; whether Kala will be able to successfully implement its commercialization plans for EYSUVIS and INVELTYS; whether the market opportunity for EYSUVIS and INVELTYS is consistent with Kala's expectations and market research; Kala's ability execute on the commercial launch of EYSUVIS on the timeline expected, or at all, including obtaining and increasing Commercial and Medicare Part D payor coverage; whether Kala will be able to generate its projected net product revenue on the timeline expected, or at all; Kala's ability to realize the anticipated benefits of the acquisition of Combangio, including the possibility that the expected benefits, synergies and growth prospects from the acquisition of Combangio will not be realized or will not be realized within the expected time period or at all, negative effects of the announcement of the acquisition of Combangio on the market price of Kala's common stock, significant transaction costs, unknown liabilities, the risk of litigation and/or regulatory actions related to the acquisition of Combangio, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials, whether results of the Phase 1b clinical trial of KPI-012 will be indicative of results for any future clinical trials and studies of KPI-012, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, whether regulatory or commercial milestones are achieved, Kala's ability to successfully integrate Combangio's business into its business, Kala's ability to retain and hire key personnel, the risk that disruption resulting from the acquisition of Combangio may adversely affect its business and business relationships, including with employees and suppliers, the sufficiency of cash resources and need for additional financing and other important factors, any of which could cause the Kala's actual results to differ from those contained in the forward-looking statements, discussed in the "Risk Factors" section of Kala's Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q and other filings Kala makes with the Securities and Exchange Commission. These forward-looking statements represent the Company's views as of the date of this release and should not be relied upon as representing the Kala's views as of any date subsequent to the date hereof. Kala does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    Investors:

    Jill Steier



    781-810-4086

    Hannah Deresiewicz



    212-362-1200

    Financial Tables:

     
    Kala Pharmaceuticals, Inc.
    Balance Sheet Data
    (in thousands)
    (unaudited)
           
     September 30,  December 31,
     2021  2020
    Cash, cash equivalents and short-term investments$124,503  $153,540
    Total assets 193,814   221,606
    Working capital (1) 121,891   149,154
    Long-term debt, net of discounts 78,491   72,243
    Other long-term liabilities 26,659   27,143
    Total stockholders' equity 61,469   99,995

    (1) The Company defines working capital as current assets less current liabilities. See the Company's consolidated financial statements for further information regarding its current assets and current liabilities.

     
     
    Kala Pharmaceuticals, Inc.
    Consolidated Statement of Operations
    (In thousands, except share and per share data)
    (Unaudited)
                
     Three Months Ended Nine Months Ended
     September 30, September 30,
     2021  2020  2021  2020 
             
    Product revenues, net$3,067  $2,220  $9,384  $4,124 
                
    Costs and expenses:           
    Cost of product revenues 908   701   2,679   1,814 
    Selling, general and administrative 25,349   23,893   81,034   54,602 
    Research and development 2,881   3,468   9,101   14,955 
    Total operating expenses 29,138   28,062   92,814   71,371 
    Loss from operations (26,071)  (25,842)  (83,430)  (67,247)
    Other income (expense):           
    Interest income 16   51   92   451 
    Interest expense (2,072)  (2,157)  (6,304)  (6,419)
    Loss on extinguishment of debt       (5,395)   
    Net loss (28,127)  (27,948)  (95,037)  (73,215)
    Net loss per share attributable to common stockholders—basic and diluted$(0.43) $(0.50) $(1.49) $(1.44)
    Weighted average shares outstanding—basic and diluted 65,050,481   56,030,717   63,766,052   50,851,167 



      
      
    Kala Pharmaceuticals, Inc.

    Reconciliation of GAAP to Non-GAAP Financial Measures 
    (In thousands) 
    (Unaudited)

                 
     Three Months Ended  Nine Months Ended
     September 30,  September 30,
     2021  2020   2021  2020 
                 
    Net loss (GAAP)$(28,127) $(27,948)  $(95,037) $(73,215)
    Add-back: stock-based compensation expense 3,928   4,261    13,340   9,249 
    Add-back: non-cash interest 435   269    1,080   782 
    Add-back: depreciation and amortization 259   220    763   674 
    Add-back: loss on extinguishment of debt        5,395    
    Non-GAAP net loss$(23,505) $(23,198)  $(74,459) $(62,510)
                 
    Cost of product revenues (GAAP)$908  $701   $2,679  $1,814 
    Less: stock-based compensation expense 38   32    109   60 
    Less: depreciation and amortization 13   13    39   39 
    Non-GAAP cost of product revenues$857  $656   $2,531  $1,715 
                 
    Selling, general and administrative expenses (GAAP)$25,349  $23,893   $81,034  $54,602 
    Less: stock-based compensation expense 3,021   3,244    10,410   6,930 
    Less: depreciation and amortization 185   150    553   450 
    Non-GAAP selling, general and administrative expenses$22,143  $20,499   $70,071  $47,222 
                 
    Research and development expenses (GAAP)$2,881  $3,468   $9,101  $14,955 
    Less: stock-based compensation expense 869   985    2,821   2,259 
    Less: depreciation and amortization 61   57    171   185 
    Non-GAAP research and development expenses$1,951  $2,426   $6,109  $12,511 
                 
    Total operating loss (GAAP)$(26,071) $(25,842)  $(83,430) $(67,247)
    Add-back: stock-based compensation expense 3,928   4,261    13,340   9,249 
    Add-back: depreciation and amortization 259   220    763   674 
    Non-GAAP total operating loss$(21,884) $(21,361)  $(69,327) $(57,324)

     



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  3. -- KPI-012 is a novel secretome with a multifactorial mechanism of action for development in PCED and other orphan ocular surface diseases driven by impaired corneal healing --
    -- KPI-012 demonstrated positive safety and efficacy results in PCED Phase 1b clinical trial --
    -- Kala expects to initiate Phase 2/3 trial in 3Q 2022 --
    --Mark S. Blumenkranz, M.D., Professor Emeritus in the Department of Ophthalmology at Stanford University, appointed to Kala's Board of Directors --
    -- Management to host conference call at 10:30 a.m. ET today --

    WATERTOWN, Mass., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative…

    -- KPI-012 is a novel secretome with a multifactorial mechanism of action for development in PCED and other orphan ocular surface diseases driven by impaired corneal healing --

    -- KPI-012 demonstrated positive safety and efficacy results in PCED Phase 1b clinical trial --

    -- Kala expects to initiate Phase 2/3 trial in 3Q 2022 --

    --Mark S. Blumenkranz, M.D., Professor Emeritus in the Department of Ophthalmology at Stanford University, appointed to Kala's Board of Directors --

    -- Management to host conference call at 10:30 a.m. ET today --

    WATERTOWN, Mass., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it has acquired Combangio, Inc., a private, clinical-stage company developing regenerative biotherapies for severe ocular surface diseases. Combangio is developing CMB-012, a novel investigational secretome therapy, now known as KPI-012, to address the complex wound healing process in persistent corneal epithelial defect (PCED) and other severe ocular diseases driven by impaired corneal healing.

    "Today's acquisition marks a pivotal moment for Kala and a meaningful acceleration toward our goal of strengthening Kala's pipeline for the treatment of front and back of the eye diseases," said Mark Iwicki, Chief Executive Officer of Kala. "KPI-012 is a highly innovative product, which leverages a multifactorial mechanism of action to address the complex process of healing severe corneal defects. KPI-012 is currently in development for PCED, with potential application across a wide range of orphan diseases of the eye. This product candidate is a natural fit with our R&D and commercial expertise, and along with our internal pipeline provides an additional opportunity to leverage our deep ophthalmic expertise to address substantial, underserved markets. We are excited to have completed the acquisition of Combangio and look forward to working alongside their talented team to integrate KPI-012 into our portfolio and ultimately deliver this therapy to transform the treatment of rare ocular surface diseases."

    KPI-012 is a novel bone marrow-derived mesenchymal stem cell (MSC) secretome comprised of biomolecules secreted by MSCs, including protease inhibitors, growth factors and neurotrophic factors, processed into a topical ocular solution. KPI-012 is currently in clinical development for the treatment of PCED, which is defined as a persistent non-healing corneal defect or wound that is refractory to conventional treatments. It is a rare disease with an estimated incidence in the U.S. of 100,000 cases and 238,000 cases in the U.S., E.U. and Japan combined and KPI-012 has received Orphan Designation for the treatment of PCED by the U.S. Food and Drug Administration (FDA). PCED can have various etiologies including neurotrophic keratitis, epithelial debridement, microbial/viral keratitis, corneal transplant, limbal stem cell deficiency and trauma, and can lead to corneal ulceration, perforation, scarring, infection and significant vision loss.

    In a Phase 1b clinical trial, seven of eight PCED patients treated with KPI-012 twice-daily showed improvement in their PCED, with six of the eight achieving complete healing during the treatment period, which ranged from one to eight weeks. Four of eight patients had complete healing within one week of treatment with the other two that achieved complete healing doing so within two to four weeks of initiation of treatment with KPI-012. All six of the healed patients remained healed through the end of follow-up, which ranged between eight and 19 weeks. There was also significant pain relief in the six patients who reported pain at baseline, with all six achieving a zero-pain score within three weeks of initiation of dosing with KPI-012.   KPI-012 was well-tolerated in the trial with no treatment-related safety issues observed.

    "KPI-012 is an exciting addition to the Kala pipeline and is an important component of our strategy to develop novel therapies for significant unmet needs in ophthalmic diseases. People living with severe ocular surface diseases are in desperate need of new and better therapeutic options to not only provide symptomatic relief but to avoid the potential vision-threatening consequences of these diseases," said Kim Brazzell, Ph.D., Chief Medical Officer of Kala. "The Phase 1b clinical data are very encouraging for PCED as well as for other rare ocular diseases that involve impaired corneal wound healing. We look forward to working together with our extensive network of corneal specialists to advance this program through clinical development and regulatory approval."

    Clinical Development Plan for KPI-012 in PCED

    Kala plans to submit an investigational new drug (IND) application to the FDA and, subject to regulatory clearance, initiate a Phase 2/3 trial of KPI-012 in the third quarter of 2022. Kala believes this trial could serve as the first of two required pivotal trials. The FDA has granted KPI-012 orphan drug designation for the treatment of PCED and the Company believes KPI-012 should meet the criteria for fast-track and breakthrough designations.

    In addition to PCED, Kala is evaluating other orphan diseases driven by impaired corneal wound healing, such as thermal/chemical injury, corneal ulcers, ocular graft vs host disease, Stevens-Johnson syndrome and limbal cell deficiency, and is looking to initiate clinical evaluation for an additional indication after the IND submission and initiation of the PCED trial.

    Board and Management Appointments

    In conjunction with the acquisition, Mark S. Blumenkranz, M.D., Chairman of Combangio, has been appointed to the Kala Board of Directors, and Darius Kharabi, President and Chief Executive Officer of Combangio, has been appointed as Chief Business Officer of Kala, both effective November 15, 2021.

    Mark S. Blumenkranz, M.D.

    "I am delighted to join the Kala Board of Directors and look forward to working with the team in its ongoing efforts to advance Kala's pipeline of innovative therapies for ocular diseases," said Dr. Blumenkranz. "As an ophthalmologist, I am acutely aware of the unmet needs that continue to exist in the treatment of eye diseases and committed to supporting the development of innovative new medicines that can deliver better outcomes to patients. I have been excited about the potential of KPI-012 for many years and I am eager to partner with the Kala team, both to continue advancing this asset, and to support the development of Kala's broader pipeline of programs for the front and back of the eye diseases."

    Dr. Blumenkranz is an ophthalmologist and vitreoretinal surgeon who is Chairman and CEO of Kedalion Therapeutics. He is also H.J. Smead Professor Emeritus in the Department of Ophthalmology at Stanford University where he served as Chairman from 1997 to 2015. He is an internationally known vitreo-retinal specialist, with notable contributions in the area of new laser systems, novel pharmaceuticals for macular diseases, ocular gene therapy and ophthalmic tele-health and technology development. Over the course of his career, Dr. Blumenkranz held leadership roles at Oculex Pharmaceuticals (acquired by Allergan), Macusight (acquired by Santen), Peak Surgical (acquired by Medtronics), Optimedica (acquired by AMO), and Oculeve (acquired by Allergan), as well as Adverum, where he served as both co-founder and Chairman of the Board. He is also co-founder and served as a director of Verana Health for ten years, and currently serves as Managing Director of Lagunita Biosciences, a biotechnology and medical investment company and incubator in Menlo Park California.. Dr. Blumenkranz received his Undergraduate, Master's in Biochemical Pharmacology, and M.D. at Brown University, completed his Ophthalmic residency training at Stanford University, and his Fellowship in vitreo-retinal diseases at the Bascom Palmer Eye Institute. 

    Darius Kharabi, J.D., M.B.A

    "On behalf of my colleagues at Combangio, we are extremely excited to join forces with Kala to accelerate the development of KPI-012 and deliver this novel therapy to people living with severe ocular surface diseases, beginning with PCED. Kala has the R&D and commercial expertise, as well as the established relationships with eye care professionals, to advance this program successfully through development and to market," said Darius Kharabi, President and Chief Executive Officer of Combangio. "I look forward to working with the Kala leadership team in my new role as Chief Business Officer to help improve outcomes and quality of life for people suffering from debilitating ocular diseases."

    Mr. Kharabi is the President and Chief Executive Officer of Combangio, as well as the co-founder of Lagunita Biosciences LLC, a biotechnology and medical investment company and incubator. He previously served in executive management for xCella and Kedalion, two Lagunita portfolio companies, helping to build early value, raise financing and recruit full-time leadership teams.  Prior to Lagunita, he served as Vice President, Corporate Development and International Sales at OrthAlign Inc., a commercial stage orthopedic surgery navigation company, where his responsibilities included the launch of the KneeAlign® total knee arthroplasty navigation product line in North America, Europe, Asia and Australia.  Mr. Kharabi started his career as a biotechnology licensing attorney at Wilson, Sonsini Goodrich & Rosati PC.  He received his B.S. in Biochemistry from Georgetown University and his J.D. and M.B.A. degrees from Stanford University.

    Transaction Terms

    Under the terms of the agreement, Kala acquired all of the outstanding equity of Combangio, and the former Combangio equityholders are entitled to receive an upfront payment of an aggregate of $5.0 million in cash, subject to customary adjustments, and an aggregate of 7,788,667 shares of Kala common stock with an aggregate value of approximately $16,122,541, consisting of (i) an aggregate of 6,815,129 shares of common stock to be issued on January 3, 2022 and (ii) an aggregate of 973,538 shares of common stock that will be held back by Kala and will be issuable fifteen months after the closing of the transaction and will serve as partial security for the satisfaction of indemnification obligations and other payment obligations of the former Combangio equityholders. The aggregate value of the post-closing stock consideration was calculated using the closing price of Kala's common stock on the Nasdaq Global Select Market on November 12, 2021, the last trading day prior to the closing. The former Combangio equityholders are also entitled to receive up to an aggregate of $105 million in cash and Kala stock upon the achievement by KPI-012 of specified development, regulatory and sales milestones and tiered royalties on worldwide net sales of KPI-012, if any, at a rate in the mid to high single digits. In addition, the former Combangio equityholders are entitled to receive a percentage rate in the high single digits of any income received by Kala from a commercial out-license of KPI-012.

    The Board of both companies have approved the transaction and the transaction closed simultaneously with execution of definitive agreements on November 15, 2021.

    Conference Call Information

    Kala will host a live conference call and webcast today at 10:30 a.m. ET to discuss its acquisition of KPI-012, as well as its third quarter 2021 financial results, which were announced in a separate press release this morning.

    To access the live conference call, please dial 866-300-4091 (domestic) or 703-736-7433 (international) and refer to conference ID 7298039. To access a live webcast including a slide presentation and subsequent archived recording of the call, please visit "Events" in the "Investor" section on the Kala website at http://kalarx.com/.

    About Kala Pharmaceuticals

    Kala is a commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFY® mucus-penetrating particle (MPP) Drug Delivery Technology to two ocular therapies, EYSUVIS® (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of signs and symptoms of dry eye disease and INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% for the treatment of post-operative inflammation and pain following ocular surgery. The Company also has a pipeline of development programs including a clinical-stage secretome product candidate initially targeting persistent corneal epithelial defects (PCED) and multiple proprietary NCE preclinical development programs targeted to address unmet medical needs, including both front and back of the eye diseases. Kala plans to submit an investigational new drug application with the FDA for KPI-012 and, subject to regulatory clearance, commence a Phase 2/3 clinical trial for PCED in the United States in third quarter of 2022. For more information on Kala, please visit www.kalarx.com.

    About Combangio

    Combangio is a clinical-stage biotechnology company focused on developing regenerative biotherapeutics based on mesenchymal stem cell ("MSC") secretomes. Combangio's lead product candidate, CMB-012 (which has been renamed KPI-012), for the treatment of persistent corneal epithelial defect ("PCED"), received orphan drug designation from the U.S. Food and Drug Administration (FDA). PCED is a disease of impaired corneal healing and is a rare disease with an estimated incidence in the United States of approximately 100,000 cases per year. Normal healing after a corneal injury follows a highly regulated process, involving growth factors, cell signaling, proliferation, migration and extracellular matrix remodeling. KPI-012 is a novel secretome-based therapy derived from bone-marrow MSC composed of biologically active components secreted from the MSCs, including protease inhibitors and growth factors, that have been shown to facilitate epithelial healing. KPI-012's multifactorial mechanism of action offers promise for the treatment of PCED and other ocular surface diseases across various etiologies.

    Kala's Forward Looking Statements:

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Any statements in this press release about Kala's future expectations, plans and prospects, including but not limited to statements about Kala's acquisition of Combangio and the other transactions contemplated by the acquisition of Combangio and any other statements about future expectations, prospects, estimates and other matters that are dependent upon future events or developments, including statements related to Kala's expectations with respect to the potential financial impact and benefits of the acquisition of Combangio, expectations with respect to potential advantages of KPI-012, the future development or commercialization of KPI-012, conduct and timelines of clinical trials, the clinical utility of KPI-012 for PCEDs, plans for regulatory filings, the market opportunity for KPI-012 for PCEDs and other indications, plans to pursue research and development of KPI-012 for other indications, the sufficiency of Kala's existing cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "likely," "will," "would," "could," "should," "continue," and similar expressions constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the impact of extraordinary external events, such as the current pandemic health event resulting from the novel coronavirus (COVID-19), and their collateral consequences, Kala's ability to realize the anticipated benefits of the acquisition of Combangio, including the possibility that the expected benefits, synergies and growth prospects from the acquisition of Combangio will not be realized or will not be realized within the expected time period or at all, negative effects of the announcement of the acquisition of Combangio on the market price of Kala's common stock, significant transaction costs, unknown liabilities, the risk of litigation and/or regulatory actions related to the acquisition of Combangio, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials, whether results of the Phase 1b clinical trial of KPI-012 will be indicative of results for any future clinical trials and studies of KPI-012, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, whether regulatory or commercial milestones are achieved, Kala's ability to successfully integrate Combangio's business into its business, Kala's ability to retain and hire key personnel, the risk that disruption resulting from the acquisition of Combangio may adversely affect its business and business relationships, including with employees and suppliers, the sufficiency of cash resources and need for additional financing and other important factors, any of which could cause the Kala's actual results to differ from those contained in the forward-looking statements, discussed in the "Risk Factors" section of Kala's Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q and other filings Kala makes with the Securities and Exchange Commission. These forward-looking statements represent the Company's views as of the date of this release and should not be relied upon as representing the Kala's views as of any date subsequent to the date hereof. Kala does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    Investor Contacts:

    Jill Steier

     

    781-996-5252

    Hannah Deresiewicz

     

    212-362-1200 



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  4. WATERTOWN, Mass., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it has changed the time of its previously scheduled financial results conference call and live audio webcast. The Company will now report its third quarter 2021 financial results and provide a business update on Monday, November 15th at 10:30 am. ET.

    The dial-in numbers to access the conference call are 866-300-4091 (domestic) or 703-736-7433 (international) using the conference ID 7298039. To access a live webcast and subsequent archived recording of the call, please visit…

    WATERTOWN, Mass., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it has changed the time of its previously scheduled financial results conference call and live audio webcast. The Company will now report its third quarter 2021 financial results and provide a business update on Monday, November 15th at 10:30 am. ET.

    The dial-in numbers to access the conference call are 866-300-4091 (domestic) or 703-736-7433 (international) using the conference ID 7298039. To access a live webcast and subsequent archived recording of the call, please visit "Events" in the "Investor" section on the Kala website at http://kalarx.com/.

    About Kala Pharmaceuticals, Inc.

    Kala is a commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFY® mucus-penetrating particle (MPP) Drug Delivery Technology to two ocular therapies, EYSUVIS® (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of signs and symptoms of dry eye disease and INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% for the treatment of post-operative inflammation and pain following ocular surgery. The Company also has a pipeline of pre-clinical development programs targeted to address unmet medical needs, including both front and back of the eye diseases. For more information on Kala, please visit www.kalarx.com.

    Investor Contacts:

    Jill Steier



    781-996-5252

    Hannah Deresiewicz



    212-362-1200



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  5. WATERTOWN, Mass., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that management will participate in the following virtual healthcare investor conferences in November 2021:

    Jefferies London Healthcare Conference
    A pre-recorded fireside chat will be made available on the company's website beginning Thursday, November 18, 2021 at 3:00 am ET/8:00 am GMT. Management will also be available for virtual one-on-one meetings on that date.

    To access the webcast and subsequent archived recording of the Jefferies fireside chat, please visit "Events" in the…

    WATERTOWN, Mass., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that management will participate in the following virtual healthcare investor conferences in November 2021:

    Jefferies London Healthcare Conference

    A pre-recorded fireside chat will be made available on the company's website beginning Thursday, November 18, 2021 at 3:00 am ET/8:00 am GMT. Management will also be available for virtual one-on-one meetings on that date.

    To access the webcast and subsequent archived recording of the Jefferies fireside chat, please visit "Events" in the "Investors" section on the Kala website at http://kalarx.com/.

    Ophthalmology Day at BTIG

    Management will participate in a virtual fireside chat moderated by Tom Shrader, PhD, CFA, BTIG Biotechnology Analyst at 10:00am ET and host virtual one-on-one meetings on Tuesday, November 30, 2021.  

    BTIG hosted events are intended for prospective and existing BTIG clients only. To listen to the live event, please contact your BTIG representative with interest.

    About Kala Pharmaceuticals, Inc.

    Kala is a commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFY® mucus-penetrating particle (MPP) Drug Delivery Technology to two ocular therapies, EYSUVIS® (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of signs and symptoms of dry eye disease and INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% for the treatment of post-operative inflammation and pain following ocular surgery. The Company also has a pipeline of pre-clinical development programs targeted to address unmet medical needs, including both front and back of the eye diseases. For more information on Kala, please visit www.kalarx.com.

    Investor Contacts:

    Jill Steier



    781-996-5252

    Hannah Deresiewicz



    212-362-1200



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