On May 7, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2021. Net loss for the first quarter was $47.1 million, or $0.66 per share, compared to net loss for the first quarter of 2020 of $39.4 million, or $0.66 per share. Cash, cash equivalents and investments totaled $460.2 million at March 31, 2021 (Press release, Cytokinetics, MAY 7, 2021, View Source,million%2C%20or%20%240.66%20per%20share. [SID1234579474]).

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"We continued to execute well in the first quarter against our ambitious plans. We recently convened a meeting with FDA related to omecamtiv mecarbil and GALACTIC-HF and are proceeding towards additional planned meetings this quarter with an expected NDA submission in the second half of the year," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "We look forward to the presentation of a secondary analysis from GALACTIC-HF which will shed further light on the impact of ejection fraction on patient outcomes. Additionally, we were pleased to complete enrollment in Cohort 2 of REDWOOD-HCM and more recently begin enrollment in the open-label extension study. We expect results from REDWOOD-HCM mid-year and are planning to initiate a pivotal Phase 3 trial by year-end."

Q1 and Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Met with the U.S. Food and Drug Administration (FDA) in Q1 and anticipate additional regulatory interactions in Q2 to inform plans to submit a New Drug Application (NDA) for omecamtiv mecarbil in 2H 2021. The planned regulatory filing is expected to be based on a single pivotal trial, GALACTIC-HF, which demonstrated a positive effect on the primary composite endpoint of cardiovascular death or heart failure events in patients receiving standard of care plus omecamtiv mecarbil

Announced that data from a secondary analysis of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) assessing the effect of omecamtiv mecarbil on clinical outcomes in relationship to patient baseline ejection fraction will be presented in a Late Breaking Clinical Trial session at the American College of Cardiology 70th Annual Scientific Session & Expo (ACC.21).

Continued conduct of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil. Expect to complete enrollment in Q2 and report results in early 2022.

Conducted market research, forecasting and other planning activities in support of the potential commercialization of omecamtiv mecarbil.

Published a manuscript entitled, "Effect of Varying Degrees of Renal Impairment on the Pharmacokinetics of Omecamtiv Mecarbil" in Clinical Pharmacokinetics.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Dosed the first patient in Cohort 2 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial designed to determine the safety and tolerability of CK-274 in patients with obstructive hypertrophic cardiomyopathy (oHCM). We subsequently completed enrollment in Cohort 2 of REDWOOD-HCM in Q1.

Opened enrollment in Cohort 3 of REDWOOD-HCM for patients whose background therapy includes disopyramide.

Activated the first site for enrollment in REDWOOD-HCM OLE, the open label extension clinical study designed to assess the long-term safety and tolerability of CK-274 in patients with symptomatic oHCM who have participated previously in REDWOOD-HCM.

Received orphan drug designation for CK-274 for the potential treatment of symptomatic HCM from the FDA.

Prepared for regulatory interactions with FDA to occur in Q2 and continuing into the second half of 2021 to inform preparations for a pivotal Phase 3 clinical trial of CK-274 in HCM, expected to begin by year-end.

Recently presented data related to the optimization of CK-274, including the first disclosure of its chemical structure, at the American Chemical Society Spring 2021 Virtual Meeting.

Enrolled the first patient in a Phase 1 study of CK-274 in China under the License and Collaboration Agreement between Cytokinetics and Ji Xing Pharmaceuticals Limited.
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Conducted start-up activities, including regulatory and institutional review board submissions, for COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), the planned Phase 3 clinical trial of reldesemtiv in patients with ALS, in preparation for the potential opening of the trial to patient enrollment in 2H 2021.

Completed joint research program under collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators.

Published a manuscript entitled "Reldesemtiv in Patients with Spinal Muscular Atrophy: A Phase 2 Hypothesis-Generating Study" in Neurotherapeutics.
Pre-Clinical Development and Ongoing Research

Continued to advance new chemical entities and to conduct IND-enabling studies with expectation of our potentially advancing 1-2 potential drug candidates in development over the next year.

Continued research activities directed to our other muscle biology research programs.
Corporate

Conducted planning activities related to the termination of the Collaboration and Option Agreement with Amgen and the transition of rights to develop and commercialize omecamtiv mecarbil, effective May 20, 2021.

Joined with the European Organisation for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD) to recognize Rare Disease Day, an international campaign elevating the public understanding of rare diseases.

Awarded Cytokinetics Communications Fellowship Grants to patient advocacy organizations serving the heart failure, HCM, ALS and SMA communities to support increased capacity in communications, disease awareness and community engagement.

Convened inaugural Heart Failure Advisory Council meeting with patients and caregivers with heart failure to inform the ongoing development of the company’s heart failure directed pipeline.
Financials

Revenues for the first quarter 2021 increased to $6.5 million from $3.8 million for the first quarter 2020 due to increased research and development revenue from our collaborations with Amgen and Astellas.

Research and development expenses for the first quarter 2021 increased to $31.6 million from $21.7 million for the first quarter of 2020. The changes were primarily due to increases in spending for COURAGE-ALS and our clinical development activities for our cardiac muscle inhibitor programs.

General and administrative expenses for the first quarter of 2021 increased to $15.6 million from $12.4 million for the first quarter in 2020, due primarily to an increase in personnel related costs including stock-based compensation and higher outside spending for commercial readiness.

We expect to revise our financial guidance mid-year once we finalize strategies and potential commercial launch plans for omecamtiv mecarbil. Executing on those strategies and plans may result in our incurring significant additional expenses that were not included in our current financial guidance. We expect that some or all of those potential expenses could be covered by our accessing additional capital through strategic partnership(s) with near term cash infusions or by equity and/or debt financings if deemed appropriate.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s first quarter 2021 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or +1 (706) 679-3078 (international) and typing in the passcode 6097958.

An archived replay of the webcast will be available via Cytokinetics’ website until May 20, 2021. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or +1 (404) 537-3406 (international) and typing in the passcode 6097958 from May 6, 2021 at 7:30 PM Eastern Time until May 20, 2021.

On May 7, 2021 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the first quarter ended March 31, 2021 (Press release, Verrica Pharmaceuticals, MAY 7, 2021, View Source [SID1234579473]).

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"This is a significant time for the Company as we ramp up our commercial readiness plans in preparation for potential FDA approval this year of VP-102 for the treatment of molluscum, a common, highly contagious skin disease with no FDA-approved treatments," said Ted White, Verrica’s President and Chief Executive Officer. "In parallel, we strengthened our financial position, raising funds and generating licensing revenues that we believe will support planned operations at least through the second quarter of 2023."

Ted White continued: "Further, we expanded our global reach by granting Torii an exclusive license to develop and commercialize VP-102 in Japan for the treatment of molluscum and common warts, executing the first strategic step in potentially bringing VP-102 to global markets."

Business Highlights and Recent Developments

The Company continued to expand its U.S. commercial operations during the quarter in preparation for the potential FDA approval of VP-102 (cantharidin 0.7% Topical Solution), and has made key hires in marketing, sales and payor functions to support product launch and commercialization. The Company has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2021 for its NDA for VP-102. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH.
On March 25, the Company closed an underwritten public offering of 2,033,899 shares of its common stock at a price to the public of $14.75 per share. The gross proceeds from the offering to Verrica were approximately $30.0 million, before offering expenses.
The Company entered into a Collaboration and License Agreement (the "Torii Agreement") with Torii Pharmaceutical Co., Ltd. ("Torii") granting Torii an exclusive license to develop and commercialize VP-102 in Japan for the treatment of molluscum and common warts. Under the terms of the Agreement, Torii made an up-front payment of $11.5 million to Verrica and has also agreed to make up to an additional $58 million in aggregate payments contingent on achievement of specified development, regulatory, and sales milestones. Torii will also make tiered transfer price payments for supply of product in the range of the mid-30s to mid-40s as a percent of net sales. Torii is responsible for all development activities and costs in support of obtaining regulatory approval in Japan.
Positive pooled results from the pivotal CAMP trials evaluating the safety and efficacy of VP-102 in the treatment of molluscum were published in the March 2021 issue of the American Journal of Clinical Dermatology.
Financial Results

First Quarter 2021 Financial Results

Verrica recognized license revenues of $12.0 million in the first quarter of 2021 related to the Torii Agreement. There were no license revenues recognized in 2020.
Research and development expenses were $5.4 million in the first quarter of 2021, compared to $4.9 million for the same period in 2020. The increase was primarily attributable to a one-time $2.3 million milestone payment to Lytix Biopharma AS upon the achievement of a regulatory milestone for LTX-315, partially offset by decreased Chemistry, Manufacturing and Controls (CMC) and clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum, external genital warts, and common warts in 2020.
General and administrative expenses were $6.6 million in the first quarter of 2021, compared to $5.0 million for the same period in 2020. The increase was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102.
For the first quarter of 2021, net loss on a GAAP basis was $0.9 million, or $0.04 per share, compared to a net loss of $9.8 million, or $0.39 per share, for the same period in 2020.
For the first quarter of 2021, non-GAAP net income was $0.6 million, or $0.02 per share, compared to a non-GAAP net loss of $8.8 million, or $0.35 per share, for the same period in 2020.
As of March 31, 2021, Verrica had aggregate cash, cash equivalents, and marketable securities of $87.7 million. The Company believes that its existing cash, cash equivalents, and marketable securities as of March 31, 2021, combined with the $11.5 million up-front payment received pursuant to the Torii Agreement in April 2021, will be sufficient to support planned operations at least through the second quarter of 2023.
Non-GAAP Financial Measures

In evaluating the operating performance of its business, Verrica’s management considers non-GAAP income from operations, non-GAAP net income (loss) and non-GAAP net income (loss) per share. These non-GAAP financial measures exclude stock-based compensation charges and non-cash interest expense that are required by GAAP. Verrica believes that non-GAAP income from operations, non-GAAP net income (loss) and non-GAAP net income (loss) per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. non-GAAP income from operations, non-GAAP net income (loss) and non-GAAP net income (loss) per share should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Non-GAAP income from operations, non-GAAP net income (loss) and non-GAAP net income (loss) per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.

About VP-102

Verricaʼs lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 is currently under U.S. Food and Drug Administration (FDA) review, with a PDUFA goal date of June 23, 2021, and could potentially be the first product approved by the FDA to treat molluscum contagiosum ― a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

About Molluscum Contagiosum (Molluscum)

There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.

On May 7, 2021 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results for the three months ended March 31, 2021 (Press release, Trillium Therapeutics, MAY 7, 2021, View Source [SID1234579472]). All financial amounts in this news release are in United States dollars, unless otherwise stated.

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"Coming off an R&D Day last week, we are very excited to have launched a new chapter in Trillium’s evolution," said Jan Skvarka, Trillium’s President and CEO. "Building on a robust foundation anchored in a demonstrated monotherapy proof of concept of TTI-622 and TTI-621 in multiple lymphoma indications, we have initiated an ambitious Phase 1b/2 program in nine patient settings across hematologic and solid tumor cancers. With a major transformation program that touched literally every aspect of our identity completed in 2020, and approximately $276 million in cash, we are very well positioned to execute the recently initiated Phase 1b/2 program, and generate a robust flow of new data over the next couple of years."

First Quarter 2021 Financial Results

Cash position: As of March 31, 2021, Trillium had cash and cash equivalents and marketable securities of $275.7 million, compared to $291.2 million at December 31, 2020. The decrease in cash and cash equivalents and marketable securities was due mainly to cash used in support of operating activities during the period.

Research and development expenses: Research and development expenses for the three months ended March 31, 2021 of $5.9 million were higher than the research and development expenses of $5.0 million for the three months ended March 31, 2020. The increase was due mainly to higher manufacturing costs to support our expanded clinical operations and higher clinical trial costs related to increased patient enrollment.

General and administrative expenses: General and administrative expenses for the three months ended March 31, 2021 of $5.4 million were lower than general and administrative expenses of $11.7 million for the three months ended March 31, 2020. The decrease is due mainly to a non-cash loss of $9.3 million on the revaluation of the deferred share unit liability in the prior period, partially offset by $2.1 million of increased stock-based compensation expense in the current period mainly relating to higher weighted average fair values of stock options outstanding and the fair valuation of stock options liabilities.

Net loss: Net loss for the three months ended March 31, 2021 of $10.9 million was lower than the loss of $16.3 million for the three months ended March 31, 2020. The net loss was lower due mainly to a non-cash loss of $9.3 million on the revaluation of the deferred share unit liability in the prior period. This was partially offset by higher stock-based compensation, manufacturing, and clinical trial expenses.

On May 7, 2021, Ultragenyx Pharmaceutical Inc. (the "Company") reported that it entered into an Open Market Sale AgreementSM (the "Sale Agreement") with Jefferies LLC (the "Agent"), pursuant to which the Company may offer and sell shares of the Company’s common stock having an aggregate offering price of up to $350,000,000, from time to time, in "at the market" offerings through the Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. The Agent will receive a commission from the Company of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sale Agreement.

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The Company is not obligated to sell, and the Agent is not obligated to buy or sell, any shares of common stock under the Sale Agreement. No assurance can be given that the Company will sell any shares of common stock under the Sale Agreement, or, if it does, as to the price or amount of shares of common stock that it sells or the dates when such sales will take place.

In the Sale Agreement, the Company agreed to indemnify the Agent against certain liabilities, including under the Securities Act of 1933, as amended, or to contribute payments that the Agent may be required to make because of such liabilities.

The shares of common stock sold pursuant to the Sale Agreement will be offered pursuant to a shelf registration statement on Form S-3 (File No. 333-253008), which became automatically effective upon filing with the U.S. Securities and Exchange Commission ("SEC") on February 12, 2021. The Company filed a prospectus supplement with the SEC on May 7, 2021 in connection with the offer and sale of shares of the Company’s common stock pursuant to the Sale Agreement.

A copy of the Sale Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the Sale Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sale Agreement.

On May 7, 2021 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, reported financial results for the first quarter of 2021 and provided a corporate update (Press release, Rexahn, MAY 7, 2021, View Source [SID1234579465]).

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"The highlight of the first quarter was our announcement of positive top-line results from the pivotal MIRA-2 Phase 3 trial investigating Nyxol eye drops for reversal of pharmacologically-induced mydriasis (pupil dilation). The highly statistically significant results provide the foundation to advance Nyxol towards NDA submission in an indication representing over 100 million annual eye exams with no commercial treatments currently available", said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. "The recent Phase 3 data further validate Nyxol’s unique mechanism of action on the iris dilator muscle, its consistent therapeutic effect of pupil diameter reduction, and its favorable safety and tolerability profile for additional refractive indications including Presbyopia and Night Vision Disturbances. We are also making progress with our second product candidate, APX3330, and are currently enrolling patients in a Phase 2 trial primarily in Diabetic Retinopathy. Overall, 2021 is off to a strong start and we look forward to more updates on our programs throughout the year including the Phase 2 Presbyopia data readout expected at the end of June."

Cam Gallagher, MBA, Chair of Ocuphire’s Board of Directors commented, "Since our public listing via reverse merger just six months ago, the management team together with Ocuphire’s clinical and manufacturing partners have successfully launched an impressive four Phase 3 and 2 clinical trials for Nyxol and APX3330, clearly demonstrating their execution capabilities. Importantly, data from multiple trials at Ocuphire have been published in several peer-reviewed journals and presented at multiple ophthalmic and healthcare banking conferences, further establishing our presence within the industry. We look forward to continuing this momentum in 2021, and with our recent positive Phase 3 data, we are excited to move ahead with our commercialization strategies for Nyxol."

Key Anticipated Future Milestones

Presbyopia: Top-line data expected end of Q2 2021 for Phase 2 VEGA-1 trial investigating a kit combination of Nyxol and low-dose 0.4% pilocarpine
Reversal of Mydriasis: Presenting Phase 3 MIRA-2 results at the 2021 American Society of Cataract and Refractive Surgeons conference in Las Vegas in July
Night Vision Disturbances: Top-line data expected end of Q3 2021 for pivotal Phase 3 LYNX-1 trial investigating Nyxol
Reversal of Mydriasis: Planning to initiate second Phase 3 MIRA-3 registration trial in 2H 2021 investigating Nyxol with results expected in early 2022
Diabetic Retinopathy and Diabetic Macular Edema: Completion of enrollment in Phase 2 ZETA-1 trial investigating APX3330 with top-line data expected early 2022
First Quarter and Recent Business Highlights

Clinical Development

Reported positive results in pivotal Phase 3 MIRA-2 trial investigating Nyxol for Reversal of Mydriasis (within 4 months of initiation) which met primary and multiple secondary endpoints demonstrating a more rapid return to baseline pupil diameter after dilation across multiple commonly used dilating agents and iris colors
Initiated ZETA-1 Phase 2 trial investigating the first-in-class oral anti-VEGF and anti-inflammatory APX3330 in Diabetic Retinopathy and Diabetic Macular Edema
Initiated Phase 2 VEGA-1 trial evaluating a kit combination of Nyxol and low-dose pilocarpine in Presbyopia with a differentiated pharmacologic approach that moderately acts on both the iris dilator and iris sphincter muscles that control pupil diameter
Presentations and Publications

Presented positive pre-clinical data supporting oral APX3330’s efficacy and sufficient exposure to the retina at the Association for Research in Vision and Ophthalmology (ARVO) virtual Annual Meeting
Published positive results from the MIRA-1 Phase 2b clinical trial evaluating the safety and efficacy of Nyxol for Reversal of Mydriasis in Optometry and Visual Science journal
Presented highlights of Nyxol presbyopia program at the 2021 Ophthalmology Innovation Summit (OIS) Presbyopia Innovation Showcase
First Quarter 2021 Financial Highlights

As of March 31, 2021, the Company had cash and cash equivalents of approximately $10.6 million.

General and administrative expenses for the three months ended March 31, 2021 were $1.7 million compared to $0.4 million for the three months ended March 31, 2020. The $1.3 million increase was primarily attributable to an increase in administrative employee headcount, stock-based compensation, professional services, insurance, and legal costs associated with the operating as a public company in the current period subsequent to the merger.

Research and development expenses for the three months ended March 31, 2021 were $3.5 million compared to $0.2 million for the three months ended March 31, 2020. The $3.3 million increase as compared to the prior period was primarily attributable to four new clinical trials and manufacturing activities for Nyxol and APX3330 as well as regulatory, preclinical, and other development activities.

The total GAAP loss from operations for the three months ended March 31, 2021 was $5.2 million compared to $2.7 million for the three months ended March 31, 2020. This included non-cash stock-based compensation expense of $494,000 and $61,000, respectively.

The quarter ended March 31, 2021 included a non-cash charge of $33.8 million related to the fair value change in warrant liabilities included in other expense. The quarter ended March 31, 2020 included a non-cash charge of $0.6 million related to interest expense on convertible notes and a $0.2 million non-cash benefit due to the fair value change in premium conversion derivatives related to convertible notes, both included in other expense. As a result, GAAP net loss attributable to common stockholders for the quarter ended March 31, 2021 was $39.0 million compared to $3.1 million for the quarter ended March 31, 2020.

Effective February 3, 2021, each investor that invested in the Pre-Merger Financing entered into a Waiver Agreement with Ocuphire. The Waiver Agreements provide for the elimination of the full ratchet anti-dilution provisions contained in the Series A Warrants (as certain of the anti-dilution provisions had previously caused liability accounting treatment for the Series A Warrants). Upon the effective date of the Waiver Agreements, the Series A Warrants were reclassified to equity. In addition, the investors agreed to waive certain rights, finalize the exercise price and number of Series A Warrants and Series B Warrants, eliminate certain financing restrictions, extend the term of certain leak-out agreements, and, in the case of certain investors, grant certain registration rights for the shares underlying the Series A Warrants.

Non-GAAP adjusted net loss was $5.2 million or ($0.47) per share for the three months ended March 31, 2021, compared with a non-GAAP adjusted net loss of $3.3 million or ($0.93) per share for the three months ended March 31, 2020. Non-GAAP adjusted net loss for the three months ended March 31, 2021 and 2020 excludes expenses for the fair value change in warrant liabilities related to the Pre-Merger Financing and premium conversion derivatives related to convertible notes, respectively. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP and non-GAAP financial measure.

For further details on Ocuphire’s financial results, refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, to be filed with the Securities and Exchange Commission.