On May 6, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, reported financial results for the quarter ended March 31, 2021 and provided recent business highlights (Press release, Aldeyra Therapeutics, MAY 6, 2021, View Source [SID1234579428]).

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"We expect 2021 to be a catalyst-rich year for Aldeyra as we continue to advance reproxalap, our lead program, toward potential commercialization in anterior ocular inflammatory disease," stated President and CEO Todd C. Brady, M.D., Ph.D. "We recently completed the Phase 3 INVIGORATE Trial of reproxalap, achieving statistically significant superiority over vehicle across all assessed signs and symptoms of allergic conjunctivitis, including ocular itching and redness. We look forward to meeting with the U.S. Food and Drug Administration in the second half of this year to discuss the INVIGORATE results and the potential submission of a New Drug Application (NDA). In addition, we remain on track to report top-line results in the second half of this year from the Phase 3 TRANQUILITY and TRANQUILITY-2 clinical trials of reproxalap in dry eye disease.

"We believe we continue to operate from a position of financial strength," Dr. Brady stated. "With the recent follow-on public offering, we expect to have sufficient capital to prepare reproxalap for NDA submission and a potential commercial launch, if approved, while investing in the clinical development of ADX-629, ADX-2191, and other product candidates in retinal and systemic immunological diseases with unmet medical need."

Recent Highlights and Program Updates

Primary, Key Secondary, and All Secondary Endpoints Met in Phase 3 INVIGORATE Allergic Conjunctivitis Clinical Trial: In the first-ever Phase 3 clinical trial of a novel investigational product in an allergen chamber, 0.25% reproxalap ophthalmic solution (reproxalap) demonstrated statistically significant improvement over vehicle for the primary endpoint of ocular itching (p<0.0001), the key secondary endpoint of ocular redness (p<0.0001), and the secondary endpoints of ocular tearing and total ocular severity score (each p<0.0001). The results of INVIGORATE, the second positive Phase 3 trial for reproxalap in allergic conjunctivitis, indicate potential clinical utility before and during exposure to moderate to high levels of pollen.
Phase 3 TRANQUILITY and TRANQUILITY-2 Dry Eye Disease Trial Results Expected in Second Half of 2021: Patient enrollment has begun in the dry eye chamber Phase 3 TRANQUILITY Trial of reproxalap. The primary endpoint of the trial is ocular redness, which was statistically lower (p=0.03) for reproxalap relative to vehicle in the TRANQUILITY run-in cohort results announced in January 2021. Tear RASP (reactive aldehyde species) levels will also be assessed. Approximately 150 dry eye disease patients are expected to be enrolled per arm. Reproxalap will be administered four times the day prior to entry into the dry eye chamber, just before entry into the chamber, and 45 minutes after chamber entry. Enrollment in TRANQUILITY is ongoing, and enrollment in the confirmatory TRANQUILITY-2 Trial is expected to begin in the second quarter of 2021. Aldeyra plans to report top-line results from both trials in the second half of this year.
Phase 2 Clinical Trial Results from ADX-629, an Orally Available RASP Inhibitor, Expected Second Half of 2021: Initial Phase 2 clinical results from ADX-629, a novel orally available RASP inhibitor currently undergoing testing in asthma, psoriasis, and COVID-19, are expected in the second half of 2021. ADX-629 represents a first-in-class systems-based therapeutic approach for an orally administered RASP inhibitor, the potential applicability of which could extend to a myriad of immune-mediated diseases that today are treated with single-target drugs that can lead to serious toxicity.
Public Offering Completed: Aldeyra sold 10,000,000 shares of its common stock at a public offering price of $12.50 per share in an underwritten public offering. The offering generated gross proceeds of $125.0 million and net proceeds of $117.3 million after deducting underwriting discounts, commissions, and estimated offering expenses.
First-Quarter 2021 Financial Summary

Cash and cash equivalents as of March 31, 2021 were $138.4 million. Based on Aldeyra’s current operating plan, the company believes that existing cash and cash equivalents, as of March 31, 2021, together with the net proceeds from the sale of common stock in the underwritten public offering in May 2021, will be sufficient to fund currently projected operating expenses through the end of 2023, including potential NDA submission for reproxalap; initial commercialization of reproxalap, if approved; and continued early and late-stage development of the company’s product candidates in ocular and systemic immune-mediated diseases.

For the quarter ended March 31, 2021, Aldeyra reported a net loss of $11.3 million, compared with a net loss of $9.9 million for the quarter ended March 31, 2020. Net loss per share was $0.25 for the quarter ended March 31, 2021, compared with $0.34 for the same period in 2020. Losses have resulted from the costs of Aldeyra’s clinical trials and research and development programs, as well as from general and administrative expenses.

Research and development (R&D) expenses were $7.7 million for the quarter ended March 31, 2021, compared with $6.6 million for the same period in 2020. The increase of $1.1 million is primarily related to clinical development and manufacturing costs, partially offset by lower personnel related costs and a decrease in preclinical costs.

General and administrative expenses were $3.1 million for the quarter ended March 31, 2021, compared with $3.0 million for the quarter ended March 31, 2020.

For the quarter ended March 31, 2021, total operating expenses were $10.8 million, compared with total operating expenses of $9.6 million for the same period in 2020.

Conference Call & Webcast Information

Aldeyra will host a conference call at 8:00 a.m. ET today to discuss its first-quarter 2021 financial results and recent highlights. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6779202. Due to the expected high demand on our conference call provider, please plan to dial in to the call at least 15 minutes prior to the start time.

A live webcast of the conference call will also be available on the Investor Relations page of the company’s website at View Source After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

On May 6, 2021 Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, and Promethera Biosciences, the leader in advanced therapy development for severe liver diseases, reported that Catalent has acquired Promethera’s cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support SA (HCTS), including its 32,400 square-foot (3,010 square-meter) facility in Gosselies, Belgium (Press release, Catalent, MAY 6, 2021, https://www.catalent.com/catalent-news/catalent-acquires-additional-facility-at-its-gosselies-belgium-campus-for-commercial-scale-plasmid-dna-manufacturing/ [SID1234579491]). The facility will accommodate Catalent’s new commercial-scale plasmid DNA (pDNA) manufacturing and will provide the opportunity for the immediate growth of Catalent’s pDNA service offering, which was recently acquired from Delphi Genetics to support the growing cell and gene therapy pipeline.

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The HCTS facility houses an existing cleanroom infrastructure, process development and quality control laboratories as well as warehouse space, and will be equipped to provide pDNA manufacturing up to a 500-liter scale. This new facility is located on Catalent’s existing campus in Gosselies, adjacent to the Delphi Genetics building. Since the purchase of MaSTherCell in March of 2020, this acquisition is the third that Catalent has made at its Gosselies location, and further expands its cell and gene therapy European Center of Excellence.

Fitting out the facility is expected to begin immediately, and will create more than 200 technical, scientific, and operational new employment positions over the next five years.

Alongside this new expansion in Gosselies, Catalent will also offer commercial-scale pDNA production capabilities at its Rockville, Maryland, facility with the addition of 500-liter scale bioreactor capacity.

"Plasmid DNA manufacturing is a critical component to many biological therapeutics, including viral vectors, mRNA, and cellular therapies. This investment allows Catalent to support these programs from development through to CGMP commercial production, offering the full horizontal supply chain," said Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. She added, "The Center of Excellence we have established in Belgium brings critical experience and expertise together on one campus, allowing for key synergies to best support our customers."

"Promethera is thrilled to divest its HCTS facility to Catalent, alongside its new strategy to concentrate activities on its core expertise and breakthrough approach using advanced therapies to restore liver health in patients with life-threatening liver diseases," explained professor Etienne Sokal, President of Promethera.

On May 6, 2021 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases with significant unmet needs, reported financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, Protara Therapeutics, MAY 6, 2021, View Source [SID1234579268]).

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"We remain on track to file an Investigational New Drug (IND) application and initiate our Phase 1 clinical study for TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) by the end of the year. Patients suffering from NMIBC have limited approved treatment options, and with the current standard-of-care facing a long-term supply shortage, there is an urgent need for effective therapies for these patients," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We look forward to completing GMP scale up and comparability and then aligning with the Food and Drug Administration (FDA) on the design of a clinical study for TARA-002 in patients with Lymphatic Malformations (LMs). This new study, together with the extensive data for OK-432, the originator compound for TARA-002, should provide a robust data package for TARA-002 in this rare pediatric indication for which there is no U.S. FDA-approved therapy."

Recent Highlights and Upcoming Milestones

TARA-002 in NMIBC

Protara remains on track to submit an IND application in the second half of 2021. Subject to the successful completion of select non-clinical studies, which are expected to be completed in the first half of 2021, and FDA acceptance of the IND application, the Company plans to commence a Phase 1 study by the end of 2021 to assess the safety and tolerability of TARA-002 in patients with NMIBC, including patients with carcinoma in situ (CIS).
TARA-002 in LMs

Based on feedback from the FDA, the Company intends to complete confirmatory, large-scale, GMP manufacturing comparability in the second half of 2021 and, upon alignment with FDA on study design, subsequently initiate a clinical study in pediatric LM patients.
IV Choline Chloride in Intestinal Failure Associated Liver Disease (IFALD)

The Company is currently undertaking a prevalence study in partnership with a large home health organization in the U.S. to enhance understanding of the appropriate patient population and will use this information to define the next steps for the development program.
Corporate Update

In April 2021, the Company announced the appointment of Martín Sebastian Olivo, M.D. as Chief Medical Officer. Dr. Olivo brings to Protara more than 15 years of experience in oncology translational and clinical research and global drug development, most recently serving as Vice President, Breast Cancer Clinical Development Lead at Gilead Sciences, Inc. (formerly Immunomedics, Inc.).
First Quarter 2021 Financial Results

As of March 31, 2021, cash, cash equivalents and investments totaled $155 million.

Research and development expenses for the first quarter of 2021 increased to $7.0 million from $3.1 million during the first quarter of 2020. The increased R&D expenses were primarily due to increases in manufacturing and regulatory expenses associated with TARA-002.

General and administrative expenses for the first quarter of 2021 decreased to $6.5 million from $7.1 million for the prior year period. The decrease was primarily due to one-time expenses related to the reverse merger, which occurred in the first quarter of 2020, off-set by an increase in personnel and related costs supporting the Company’s growth.

For the first quarter of 2021, Protara reported a net loss of $13.5 million, or $1.20 per share, compared with a net loss of $10.1 million, or $1.81 per share, for the same period in 2020. Net loss for the first quarter of 2021 included approximately $2.7 million of stock-based compensation expenses.
About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan and Taiwan by Chugai Pharmaceutical Co., Ltd. Protara successfully demonstrated initial manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a strong immune cascade. Neutrophils, monocytes and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins IL-6, IL-8, IL-12, interferon (IFN)-gamma, tumor necrosis factor (TNF)-alpha, and vascular endothelial growth factor (VEGF) are secreted by immune cells to induce a strong local inflammatory reaction and destroy the abnormal cells.

About Non-Muscle Invasive Bladder Cancer

Bladder cancer is the 6th most common cancer in the United States, with non-muscle invasive bladder cancer (NMIBC) representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle. The current standard of care for high-grade NMIBC includes intravesical Bacillus Calmette-Guerin (BCG).

About Lymphatic Malformations

Lymphatic malformations (LMs) are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Most LMs are present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% detected at birth and 90% diagnosed before the age of 3 years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels, lymphatics; recurrent infection, and cosmetic and other functional disabilities.

About IV Choline Chloride and Intestinal Failure-associated Liver Disease (IFALD)

IV Choline Chloride is an investigational, intravenous (IV) phospholipid substrate replacement therapy initially in development for patients receiving parenteral nutrition (PN) who have IFALD. Choline is a known important substrate for phospholipids that are critical for healthy liver function. Because PN patients cannot sufficiently absorb adequate levels of choline and no available PN formulations contain sufficient amounts of choline to correct this deficiency, PN patients often experience a prolonged progression to hepatic failure and death, with the only known intervention being a dual small bowel/liver transplant. If approved, IV Choline Chloride would be the first approved therapy for IFALD. It has been granted Orphan Drug Designations (ODDs) by the FDA for the treatment of IFALD and the prevention of choline deficiency in PN patients.

On May 6, 2021 ChromaDex Corp. (NASDAQ:CDXC) reported first quarter 2021 financial results (Press release, ChromaDex, MAY 6, 2021, View Source [SID1234579340]).

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First Quarter 2021 and Recent Highlights

Total net sales of $14.7 million, up 2% from $14.3 million in the year ago quarter.
Tru Niagen net sales of $12.4 million, a 12% increase from the year ago quarter.
Gross margin of 62.9%, a 500 basis point increase from the year ago quarter.
Net loss was ($7.4) million or ($0.12) per share, down $0.02 per share year-over-year.
Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a loss of ($0.7) million, a $0.4 million decline year-over-year.
Announced retail distribution of Tru Niagen in Walmart stores across the United States beginning in June 2021.
Announced strategic supply agreement with Health & Happiness Group (H&H), a global leader in premium health, human and pet nutrition and personal care brands to sell Niagen in its exclusively formulated Swisse products.
Announced strategic supply agreement with Ro, a healthcare technology company, to sell Niagen in specially-formulated Roman products.
Appointed former Nestlé executive, Fadi Karam as Chief Marketing Officer.
Appointed Dr. David L. Katz, a globally recognized authority on lifestyle medicine, to the ChromaDex Scientific Advisory Board.
"This has been an incredible year for ChromaDex strategically," said ChromaDex CEO, Rob Fried. "We signed three important deals with Walmart, H&H, and Ro. We also strengthened our balance sheet with a $25 million capital raise and announced the results of exciting scientific research on Niagen. We had some short-term supply chain disruptions that impacted first quarter sales, but the long-term prospects look stronger than ever."

Results of operations for the three months ended March 31, 2021

For the three months ended March 31, 2021 ("Q1 2021"), ChromaDex reported net sales of $14.7 million, up 2% compared to $14.3 million in the first quarter of 2020 ("Q1 2020"). The increase in Q1 2021 revenues was driven by growth in sales of Tru Niagen, largely offset by lower Niagen and other ingredient sales.

Gross margin percentage improved by 500 basis points to 62.9% in Q1 2021 compared to 57.9% in Q1 2020. The improvement in gross margin percentage was driven by the positive impact of increased Tru Niagen consumer product sales and product cost savings initiatives.

Operating expenses increased by $2.4 million to $16.6 million in Q1 2021, compared to $14.2 million in Q1 2020. The increase in operating expenses was driven by $1.8 million of higher selling and marketing expenses, and an increase of $0.7 million in general and administrative expense, partially offset by $0.1 million of lower research and development expense. The increase in general and administrative expense was driven by $2.6 million of higher legal expense, partially offset by $1.0 million of lower severance and restructuring expenses and $0.8 million of lower shares-based compensation expense.

The net loss for Q1 2021 was ($7.4) million or ($0.12) per share as reported compared to a net loss of ($5.9) million or ($0.10) per share for Q1 2020 as reported. Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a loss of ($0.7) million for Q1 2021, compared to a loss of ($0.3) million for Q1 2020, a $0.4 million decline.

ChromaDex defines Adjusted EBITDA excluding total legal expense as net income or (loss) which is adjusted for interest, income tax, depreciation, amortization, non-cash stock compensation costs, severance and restructuring expense, bad debt expense related to Elysium Health and total legal expense.

For Q1 2021, the net cash flow from operating activities was ($5.4) million, versus ($5.2) million in Q1 2020.

2021 Outlook

Looking forward, for the full year, the Company expects continued, steady revenue growth driven by its global ecommerce business, as well as growth with existing and new strategic partners, and that the growth rate will accelerate beginning in the second quarter. The Company expects continued gross margin improvement to slightly better than 60%, roughly flat R&D expense and slightly higher selling and marketing expense as a percentage of net sales year-over-year. The Company expects slightly higher general and administrative expense, excluding severance, restructuring and legal expense. The Company plans to increase investments and resources to drive brand awareness and accelerate its R&D pipeline to capitalize on growth in the NAD+ market globally.

Investor Conference Call

ChromaDex management will host an investor conference call to discuss the first quarter results and provide a general business update on Thurs., May 6, at 4:30 p.m. ET.

Participants should call in at least 10 minutes prior to the call. The dial-in information is as follows:

The earnings press release, and its accompanying financial exhibits, will be available on the Investor Relations section of the Company website, www.chromadex.com.

On May 6, 2021 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, reported first quarter 2021 financial results and operational progress (Press release, Codiak Biosciences, MAY 6, 2021, View Source [SID1234579356]).

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"We are making excellent progress with our clinical and preclinical programs, which continue to generate further confirmatory evidence that our engEx exosome engineering and manufacturing platform can harness exosomes as delivery vehicles for potent and selective therapeutics, not only in immuno-oncology, but potentially in vaccines, gene therapy and neuro-oncology/neurology as well," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "We remain on track to deliver safety, biomarker and preliminary efficacy data from our exoIL-12 and exoSTING clinical programs in oncology and file an IND for our third program, exoASO-STAT6, later this year."

First Quarter 2021 and Recent Highlights

Reported positive Phase 1 results for exoIL-12 confirming local pharmacology and dose selection for safety and efficacy trial in patients with early-stage cutaneous T cell lymphoma (CTCL)
Progressed with subject dosing in the Phase 1/2 clinical trial of exoSTING for the treatment of advanced/metastatic, recurrent and injectable solid tumors
Continued to advance exoASO-STAT6 for the intravenous treatment of myeloid-rich cancers through IND-enabling studies
Detailed versatility of Codiak’s engEx Platform in manuscript published in Molecular Therapeutics, a Cell partner journal
Presented pharmacokinetic/pharmacodynamic and tolerability data from healthy volunteer portion of the exoIL-12 Phase 1 clinical trial and preclinical data from the exoASO-STAT6 program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 10-15
Published manuscript highlighting the exoSTING preclinical program in Communications Biology, a Nature Research publication
Anticipated Milestones and Events

Four poster presentations at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 24th Annual Meeting on May 11, including new preclinical data on exoAAV, exoVACC, exoASO-STAT6, and the ability of engineered exosomes to direct tropism to neuronal cells of interest
Safety, biomarker and preliminary pharmacodynamics and efficacy data from the exoSTING Phase 1/2 clinical trial in patients with solid tumors continue to be expected mid-2021, within the third quarter
Investigational New Drug (IND) application filing for exoASO-STAT6 anticipated during the second half of 2021 to enable initiation of clinical trials
Safety, biomarker and preliminary pharmacodynamics and efficacy data in CTCL patients from the exoIL-12 Phase 1 trial expected by year-end 2021
First Quarter 2021 Financial Results

Total revenues for the quarter ended March 31, 2021 were $13.2 million, compared to $0.1 million for the same period in 2020. This increase was primarily due to the mutual agreement between the Company and Jazz Pharmaceuticals to discontinue their work on exoASO-STAT3, one of five oncogene targets subject to the Collaboration and License Agreement by and between Codiak and Jazz Pharmaceuticals. The Company recognized the remaining $10.9 million in deferred revenue allocated to this target as revenue during the three months ended March 31, 2021.

Net loss for the quarter ended March 31, 2021 was $10.3 million, compared to a net loss of $22.5 million for the same period in 2020. Net loss for the quarter was driven primarily by clinical development, general and administrative, and personnel expenses, and ongoing development of the engEx Platform, offset in part by the $10.9 million in deferred revenue described above.

Research and development expenses were $16.6 million for the quarter ended March 31, 2021 compared to $18.4 million for the same period in 2020. The decrease in research and development expenses was driven primarily by lower manufacturing and preclinical costs as our lead assets progressed into the clinic during the second half of 2020.

General and administrative expenses were $6.6 million for the quarter ended March 31, 2021 compared to $4.2 million for the same period in 2020. The increase was driven primarily by an increase in personnel costs and costs associated with transitioning to a public company.

As of March 31, 2021, Codiak had cash, cash equivalents, and marketable securities of approximately $130.3 million.