On May 7, 2021 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial results for the first quarter ended March 31, 2021 (Press release, Radius, MAY 7, 2021, View Source [SID1234579464]).

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The following are key components of Q1, 2021 performance:

Q1, 2021 FINANCIAL HIGHLIGHTS:

Total net revenue improved by 17% year-over-year: $56 million in 2021 vs. $48 million in 2020
TYMLOS U.S. product net revenue down 6% year-over-year: $45 million in 2021 vs. $48 million in 2020
Reduced unit volumes from inventory channel destocking plus volatility in patient activity as a result of Covid-19 during 2020; there was a partial offset from an increase in net price
TYMLOS U.S. new patient adds grew by 14% in Q1, 2021 vs. Q4, 2020
Strong cash balance: $115 million of cash, cash equivalents and marketable securities as of 3/31/2021
Strategic and proactive management of capital structure:
Completed $175 million financing transaction in March, 2021
Redeemed ~37% of aggregate principal amount of the existing 3.00% convertible notes
Eliminated potential future dilution by ~2 million shares (~4.9% of outstanding shares)
Improved financial flexibility with a more balanced mix of secured and unsecured tranches
Added cash to the balance sheet to enhance liquidity
BUSINESS HIGHLIGHTS:

Abaloparatide:

On May 1, 2021, Humana added TYMLOS to the formularies of its Medicare Advantage Plans
Impact #1: adds ~5 million beneficiaries, which moves Medicare Part D coverage from 83% to 91%
Impact #2: increases coverage for first line PMO patients with history of fracture from 77% to 78%
Q1 TYMLOS new patient prescribers: 42 of top 50 HCP’s are now orthopedic or specialist bone practices
New patient growth for this group (the 42) was 26% vs. 14% for total Q1 TYMLOS prescriber activity
Re-submission of abaloparatide to the EMA targeted to occur in Q4, 2021
TYMLOS Black Box Warning: FDA process ongoing with clarity expected in Q4, 2021
Submitted data from the histomorphometry study for inclusion in the abaloparatide label
Elacestrant:

EMERALD phase 3 trial with our partner, Menarini Group, remains on track for 2H, 2021 topline readout
RAD011:

Type C meeting with the FDA in June, 2021 for PWS phase 3 protocol review
RAD011 previous data to be presented at the PWSA/USA conference June 23-25, 2021
Additional orphan indications being assessed with 2H, 2021 timetable to finalize plan(s)
Hired Head of Science and Technology for CBD, cannabinoid derivatives, formulations and delivery
First Quarter 2021 Financial Results

Three Months Ended March 31, 2021

Net Loss
For the three months ended March 31, 2021, Radius reported a net loss of $15.7 million, or $0.34 per share, compared to a net loss of $37.7 million, or $0.81 per share, for the three months ended March 31, 2020.

For the three months ended March 31, 2021, non-GAAP adjusted net loss, was $8.6 million, or $0.18 per share, compared to non-GAAP adjusted net loss of $27.4 million, or $0.59 per share, for the three months ended March 31, 2020.

Revenue
For the three months ended March 31, 2021, TYMLOS net product revenues were $45.3 million compared to approximately $47.9 million for the three months ended March 31, 2020.

For the three months ended March 31, 2021, license revenue was $11.0 million. No license revenue was recognized for the three months ended March 31, 2020.

Costs and Expenses
For the three months ended March 31, 2021, research and development expense was $31.4 million compared to $39.0 million for the three months ended March 31, 2020, a decrease of $7.6 million, or 19%. This decrease was primarily driven by a decrease of $3.3 million in abaloparatide-TD program cost, a $4.8 million decrease in compensation expense, which is comprised of a $1.1 million decrease in compensation expense and $3.7 million of billed reimbursable expenses, and a $7.7 million decrease in elacestrant program costs, which is comprised of a $2.9 million increase in gross program expenses offset by $10.6 million of billed reimbursable expenses. These decreases were partially offset by a $5.3 million increase in abaloparatide-SC program costs and a $2.9 million increase in professional fees and other expenses.

For the three months ended March 31, 2021, selling, general and administrative expenses were $34.1 million compared to $36.4 million for the three months ended March 31, 2020, a decrease of $2.3 million, or 6%. This decrease was primarily the result of a $0.4 million decrease in travel and entertainment expenses, a $3.6 million decrease in compensation cost, and a $0.4 million decrease in other operating costs. These decreases were partially offset by a $1.9 million increase in professional support costs, and a $0.2 million increase in occupancy and depreciation costs

On May 7, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported that David Meline, Chief Financial Officer, and Lavina Talukdar, Senior Vice President & Head of Investor Relations, will participate in a fireside chat at the Bank of America 2021 Healthcare Conference on May 13th, 2021 at 11:00 a.m. ET (Press release, Moderna Therapeutics, MAY 7, 2021, View Source [SID1234579485]).

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A live webcast will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for 30 days following the presentation.

On May 7, 2021 photonamic GmbH & Co. KG (Head office: Pinneberg, Germany; CEO: Ulrich Kosciessa, Ph.D.) ("photonamic"), a subsidiary of SBI Holdings, Inc. (Head office: Minato-ku, Tokyo; Representative Director, President and CEO: Yoshitaka Kitao) the leader in the pharmaceutical development, translation and global commercialization of 5-aminolevulinic acid ("5-ALA") (*) reported that its Canadian subsidiary SBI ALApharma Canada Inc. (Head office: Toronto, Canada; CEO & CTO, Dr. Ralph DaCosta) ("SBI Canada") has enrolled the first patient in its Pivotal Phase 3 randomized controlled trial (RCT) evaluating the safety and efficacy of PD G 506 A (5-ALA HCl) in margin assessment during breast conserving surgery (ClinicalTrials.gov Identifier: NCT04815083) (Press release, photonamic, MAY 7, 2021, View Source;co-kg-germany-enrolls-first-patient-in-pivotal-phase-3-clinical-trial-of-pd-g-506-a-5-ala-hcl-and-eagle-fluorescence-imaging-system-for-breast-conserving-surgery-301286333.html [SID1234579501]). This important milestone occurs on the heal of the company’s FDA IND clearance for the RCT on April 23, 2021. The multicenter trial involves 20 clinical centers in the United States and Canada and will use SBI Canada’s proprietary intraoperative handheld Eagle Fluorescence Imaging SystemTM to visualize PD G 506 A-induced protoporphyrin IX (PpIX) fluorescence.

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SBI Canada was established in 2019 as part of photonamic’s strategic acquisition of the oncology business from MolecuLight Inc. (Toronto, Canada). Data from an earlier Phase 2 clinical study at Princess Margaret Cancer Center demonstrated that PD G 506 A-induced PpIX fluorescence (known to be selective for cancerous tissues) can be visualized in surgical specimens and within the surgical cavity in real-time using the compact fully handheld camera of the Eagle Fluorescence Imaging SystemTM.

"We are pleased having accomplished this milestone in our development for breast cancer surgery program" explains Ulrich Kosciessa, photonamic GmbH & Co. KG’s CEO. "It is an important step on our pathway to utilize the capabilities of 5-ALA as a precursor of PpIX and its tumor selectivity together with innovative technologies to help improve the lives of cancer patients around the world. With our proprietary handheld Eagle imaging device technology of our subsidiary SBI Canada, surgeons will now be able to investigate the surgical cavity following conventional lumpectomy allowing them to identify residual disease as part of this Phase 3 trial in breast cancer surgery". "This will allow us to further develop our technology to one day benefit breast cancer patients in a manner similar to our current 5-ALA based product currently FDA approved for neurosurgery. This product similarly helps neurosurgeons around the world to perform fluorescence-guided glioblastoma surgery."

"We are delighted at achieving both FDA IND clearance and the first patient enrolled in our Pivotal Phase 3 trial within days of each other", says Dr. Ralph DaCosta, SBI Canada’s CEO & CTO. "These achievements are important markers of progress in our on-going program to investigate 5-ALA and our novel Eagle imaging technology to improve intraoperative margin assessment and fluorescence-guided surgery. Our initial focus is on breast cancer surgery, but this work lays the foundation for other cancers where real-time visualization of carcinoma during surgery is a clinical priority". "Despite the on-going COVID pandemic, our outstanding SBI Canada team, together with the support from the SBI group of companies have managed to bring us to this critical stage in clinical translation in breast cancer surgery", says DaCosta.

(*) 5-aminolevulinic acid ("5-ALA") is an endogenous amino acid derivative produced in mitochondria. Apart from its natural role as an important natural substance metabolized to heme and cytochromes serving the energy production in the mitochondrial membranes, 5-ALA is known to metabolize into the (pink/red) fluorescent compound protoporphyrin IX (PpIX) in cancer cells. This fluorescence can be detected with the appropriate instrumentation. In addition, PpIX, is a well-known photosensitizer used in photodynamic therapy of cancers.

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.

On May 7, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it will release its financial results for the first quarter 2021 and business update on Friday, May 14, 2021 (Press release, Protalix, MAY 7, 2021, View Source [SID1234579486]). The Company’s management will host a conference call to discuss the financial results and provide a business update on recent corporate and clinical developments at 8:30 a.m. Eastern Daylight Time (EDT).

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The conference call will be webcast live from the Company’s website and will be available via the following links:

Webcast Details:

Company Link: View Source
Webcast Link: View Source
Conference ID: 13719725

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.