Le Lézard
Classified in: Health, Science and technology, Business
Subjects: EARNINGS, Product/Service, Personnel, Share Issue

Rallybio Reports First Quarter 2022 Financial Results


Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today reported financial results for the first quarter ended March 31, 2022 and provided an update on recent program and corporate developments.

"We continue to move forward with our mission of discovering, developing, manufacturing and delivering therapies that meaningfully improve the lives of people with devastating rare diseases," said Martin Mackay, Ph.D., Chief Executive Officer of Rallybio. "We announced this morning that we completed our first acquisition as a public company, in-licensing RLYB331, a highly differentiated product candidate that could transform the treatment of severe, non-malignant hematological disorders. This transaction is an excellent example of our strategy of expanding our pipeline by investing in assets that have a clear mechanism of action, address a significant unmet patient need, and are complementary to our existing portfolio."

Dr. Mackay continued, "In parallel, we advanced our two clinical-stage programs, RLYB212 and RLYB116. We are pleased to announce today the initiation of the Phase 1b proof-of-concept study of RLYB212, which is designed to establish the ability of RLYB212 to rapidly eliminate transfused HPA-1a positive platelets from HPA-1a negative healthy subjects. We look forward to reporting data from this study, as well as our ongoing Phase 1 study of RLYB116, later this year."

Recent Business Highlights and Upcoming Milestones:

Maternal Fetal Blood Disorders

In January 2022, Rallybio announced that the first subjects were dosed in the Phase 1 study of RLYB212, a novel human monoclonal anti-HPA-1a antibody in development for the prevention of FNAIT (fetal and neonatal alloimmune thrombocytopenia). This single-blind, placebo-controlled Phase 1 study is designed to evaluate the safety and pharmacokinetics (PK) of single and repeat subcutaneous doses of RLYB212 in HPA-1a negative healthy subjects.

The Company announced today that it has now initiated the Phase 1b proof-of-concept study to establish the ability of RLYB212 to rapidly eliminate transfused HPA-1a positive platelets from the circulation of HPA-1a negative healthy subjects. Rallybio expects initial data from this proof-of-concept study in the third quarter of 2022.

In parallel, Rallybio continues to advance the FNAIT natural history alloimmunization study, with the first patient screened in March 2022. This non-interventional study is designed to inform on the frequency of women at higher risk for FNAIT across a broad population of pregnant women of different racial and ethnic characteristics, and the occurrence of HPA-1a alloimmunization in these women. The Company also plans that the data from this study contribute to a control dataset for a future single armed registration trial for RLYB212.

Complement Dysregulation

In the first quarter of 2022, Rallybio initiated a Phase 1 study in healthy participants of RLYB116, a novel, potentially long-acting, subcutaneously administered inhibitor of complement factor 5, or C5, in development for the treatment of patients with complement-related diseases. The single-blind, placebo-controlled dose escalation study is designed to evaluate the safety, PK, and pharmacodynamics of single dose RLYB116 in healthy volunteers and remains on track, with initial data expected in the second half of 2022.

Rallybio continues to advance development of RLYB114 for intravitreal administration for the treatment of ophthalmic disorders.

Metabolic Disorders

Rallybio, together with its partner Exscientia, continues to work toward the selection of a development candidate to advance into the clinic targeting ENPP1 for the treatment of patients with hypophosphatasia (HPP). Investigational new drug (IND)-enabling studies are expected to commence in the second half of 2022.

Hematological Disorders

Rallybio announced today that it has obtained worldwide exclusive rights to Sanofi's KY1066, now referred to as RLYB331, a preclinical potentially first-in-class antibody. RLYB331 has the potential to address a significant unmet need for patients with severe anemias with ineffective erythropoiesis and iron overload including beta thalassemia and a subset of myelodysplastic syndromes. Currently these patients are underserved by the existing standard of care.

RLYB331 is a monoclonal antibody that inhibits Matriptase-2 (MTP-2). The inhibition of MTP-2 significantly increases levels of hepcidin, decreases iron load and treats ineffective erythropoiesis.

Rallybio plans to initiate IND-enabling activities for RLYB331 to support transition of the asset into clinical development.

Corporate

In April 2022, Rallybio announced the appointments of Christine Nash, MBA and Hui Liu, Ph.D., to its Board of Directors. Ms. Nash currently serves as Board Chair and senior advisor to the President and CEO at The CM Group and brings nearly 20 years of commercial and product launch experience in rare diseases. Dr. Liu is the Executive Vice President, Chief Business Officer and Head of U.S. at Merus N.V., with 25 years of experience in business development, finance, and strategy. In conjunction with these appointments, Rallybio also announced that Tim Shannon, M.D., will resign from Rallybio's Board of Directors, effective May 24, 2022.

First Quarter 2022 Financial Results:

About Rallybio

Rallybio is a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases. Since its launch in January 2018, Rallybio has built a portfolio of promising product candidates, which are now in development to address rare diseases in the areas of hematology, immuno-inflammation, maternal fetal health, and metabolic disorders. The Company's mission is being advanced by a team of highly experienced biopharma industry leaders with extensive research, development, and rare disease expertise. Rallybio is headquartered in New Haven, Connecticut, with an additional facility at the University of Connecticut's Technology Incubation Program in Farmington, Connecticut. For more information, please visit www.rallybio.com.

Forward-Looking Statements

This press release contains forward-looking statements that are based on our management's beliefs and assumptions and on currently available information. In some cases, forward-looking statements can be identified by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements concerning, initiation and timing of our planned studies for RLYB212 and RLYB116, and the timing of the availability of data from such studies, the initiation and timing of our pre-IND enabling studies for our ENPP1 inhibitor, and the timing of the availability of data from such studies, and the therapeutic effects of RLYB331. The forward-looking statements in this press release are only predictions and are based largely on management's current expectations and projections about future events and financial trends that management believes may affect Rallybio's business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our ability to successfully initiate and conduct our planned clinical trials, including the FNAIT natural history study, and the Phase 1 and 1b clinical trials for RLYB212 and the Phase 1 study for RLYB116, and complete such clinical trials and obtain results on our expected timelines, or at all, whether our cash resources will be sufficient to fund our operating expenses and capital expenditure requirements and whether we will be successful raising additional capital, our ability to identify new product candidates and successfully acquire such product candidates from third parties, our ability to integrate RLYB331 into our pipeline, competition from other biotechnology and pharmaceutical companies, and those risks and uncertainties described in Rallybio's filings with the U.S. Securities and Exchange Commission (SEC), including Rallybio's Annual Report on Form 10-K for the period ended December 31, 2021, and subsequent filings with the SEC. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we are not obligated to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.

RALLYBIO CORPORATION

SELECTED CONDENSED CONSOLIDATED FINANCIAL INFORMATION


Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

 

 

 

FOR THE THREE MONTHS ENDED
MARCH 31,

 

(in thousands, except share and per share amounts)

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

7,648

 

 

$

9,037

 

General and administrative

 

 

6,670

 

 

 

3,787

 

Total operating expenses

 

 

14,318

 

 

 

12,824

 

Loss from operations

 

 

(14,318

)

 

 

(12,824

)

Other income (expenses):

 

 

 

 

 

 

Interest income

 

 

97

 

 

 

17

 

Interest expense

 

 

?

 

 

 

(10

)

Other income

 

 

113

 

 

 

24

 

Total other income, net

 

 

210

 

 

 

31

 

Loss from continuing operations

 

 

(14,108

)

 

 

(12,793

)

Loss on investment in joint venture

 

 

390

 

 

 

482

 

Net loss

 

$

(14,498

)

 

$

(13,275

)

 

 

 

 

 

 

 

Net loss per common share, basic and diluted

 

$

(0.48

)

 

$

(0.60

)

Weighted average common shares outstanding, basic and diluted

 

 

30,318,405

 

 

 

22,244,883

 

 

 

 

 

 

 

 

Other comprehensive loss:

 

 

 

 

 

 

Net unrealized loss on marketable securities

 

 

122

 

 

 

?

 

Other comprehensive loss

 

 

(122

)

 

 

?

 

Comprehensive loss

 

$

(14,620

)

 

$

(13,275

)

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets (Unaudited)

 

(in thousands)

 

MARCH 31,
2022

 

 

DECEMBER 31,
2021

 

Cash, cash equivalents, and marketable securities

 

$

161,409

 

 

$

175,334

 

Total assets

 

 

169,353

 

 

 

182,185

 

Total liabilities

 

 

6,317

 

 

 

6,583

 

Total stockholders' equity

 

 

163,036

 

 

 

175,602

 

 


These press releases may also interest you

2 jui 2022
Cheba Hut, a fast-growing brand breaking the mold of mundane fast-casual concepts by becoming the first marijuana-themed sandwich "joint", has opened its fifth Texas location ? owned and operated by husband/wife Chance and Angie Steed. The opening is...

2 jui 2022
In the second quarter, we produced over 258,000 vehicles and delivered over 254,000 vehicles, despite ongoing supply chain challenges and factory shutdowns beyond our control. June 2022 was the highest vehicle production month in Tesla's history....

2 jui 2022
The Boulder Group announced the release of its 2nd Quarter Net Lease Research Report today. Cap rates in the single tenant net lease sector increased slightly or were unchanged in the second quarter of 2022. Single tenant cap rates increased by 5 and...

2 jui 2022
In-depth analysis and data-driven insights on the impact of pandemic on the Organization And Change Management Consulting market, predicts that this market expects a price change of 5%-6% during the forecast period. ...

2 jui 2022
The Conference of Presidents of Major Italian American Organizations (COPOMIAO) is working closely with the New Jersey Italian Heritage Commission (NJIHC) on the national rollout of an equitable, diverse and inclusive curriculum model that uses...

2 jui 2022
Xinghuo Blockchain Infrastructure and Facility (Xinghuo BIF) and Zetrix have jointly announced the introduction of Blockchain-based Identifiers (BID) / Verifiable Credentials (VC) and Blockchain-based E-signing services to international markets, a...



News published on 10 may 2022 at 08:05 and distributed by: