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Rallybio Reports Third Quarter 2024 Financial Results and Provides Business Updates

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Rallybio (RLYB) reported Q3 2024 financial results with a net loss of $11.5 million ($0.26 per share), compared to $18.4 million loss in Q3 2023. Revenue was $0.3 million, with cash position of $75.1 million providing runway into mid-2026. The company received CTA approvals for RLYB212 Phase 2 clinical trial, with screening expected to begin in Q4 2024. R&D expenses decreased to $8.2 million from $13.3 million, while G&A expenses reduced to $4.1 million from $6.1 million year-over-year, primarily due to workforce reduction and lower development costs.

Rallybio (RLYB) ha riportato i risultati finanziari del terzo trimestre 2024, registrando una perdita netta di 11,5 milioni di dollari (0,26 dollari per azione), rispetto a una perdita di 18,4 milioni di dollari nel terzo trimestre 2023. I ricavi sono stati di 0,3 milioni di dollari, con una posizione di liquidità di 75,1 milioni di dollari che garantisce una solidità finanziaria fino a metà 2026. L'azienda ha ricevuto approvazioni CTA per il trial clinico di fase 2 di RLYB212, con inizio dello screening previsto per il quarto trimestre 2024. Le spese per ricerca e sviluppo sono diminuite a 8,2 milioni di dollari, rispetto ai 13,3 milioni dell'anno precedente, mentre le spese generali e amministrative sono scese a 4,1 milioni di dollari, rispetto ai 6,1 milioni dell'anno precedente, principalmente a causa della riduzione della forza lavoro e dei costi di sviluppo inferiori.

Rallybio (RLYB) informó los resultados financieros del tercer trimestre de 2024, con una pérdida neta de 11,5 millones de dólares (0,26 dólares por acción), en comparación con una pérdida de 18,4 millones de dólares en el tercer trimestre de 2023. Los ingresos fueron de 0,3 millones de dólares, con una posición de efectivo de 75,1 millones de dólares que proporciona liquidez hasta mediados de 2026. La compañía recibió aprobaciones de CTA para el ensayo clínico de fase 2 de RLYB212, con el inicio del cribado previsto para el cuarto trimestre de 2024. Los gastos de I+D disminuyeron a 8,2 millones de dólares desde 13,3 millones, mientras que los gastos generales y administrativos se redujeron a 4,1 millones de dólares desde 6,1 millones interanualmente, principalmente debido a la reducción de personal y menores costos de desarrollo.

Rallybio (RLYB)는 2024년 3분기 재무 결과를 발표했으며, 순손실은 1150만 달러 (주당 0.26달러)로, 2023년 3분기 1840만 달러의 손실에 비해 개선되었습니다. 수익은 30만 달러였으며, 7510만 달러의 현금 보유량으로 2026년 중반까지 운영이 가능합니다. 이 회사는 RLYB212의 2상 임상 시험에 대한 CTA 승인을 받았으며, 스크리닝은 2024년 4분기부터 시작될 예정입니다. 연구 개발 비용은 1330만 달러에서 820만 달러로 감소하였고, 일반 및 관리 비용은 연간 기준으로 610만 달러에서 410만 달러로 감소하였으며, 이는 주로 인력 감축 및 개발 비용 절감 때문입니다.

Rallybio (RLYB) a annoncé ses résultats financiers pour le troisième trimestre 2024, avec une perte nette de 11,5 millions de dollars (0,26 dollar par action), contre une perte de 18,4 millions de dollars au troisième trimestre 2023. Le chiffre d'affaires s'élevait à 0,3 million de dollars, avec une position de trésorerie de 75,1 millions de dollars permettant de soutenir l'entreprise jusqu'à mi-2026. La société a reçu des approbations CTA pour l'essai clinique de phase 2 de RLYB212, dont le dépistage est prévu pour le quatrième trimestre 2024. Les dépenses en R&D ont diminué à 8,2 millions de dollars contre 13,3 millions de dollars, tandis que les dépenses générales et administratives ont baissé à 4,1 millions de dollars contre 6,1 millions de dollars d'une année sur l'autre, principalement en raison de la réduction des effectifs et des coûts de développement inférieurs.

Rallybio (RLYB) berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 mit einem Nettoverlust von 11,5 Millionen Dollar (0,26 Dollar pro Aktie), verglichen mit einem Verlust von 18,4 Millionen Dollar im dritten Quartal 2023. Der Umsatz betrug 0,3 Millionen Dollar, mit einer liquiden Mittelausstattung von 75,1 Millionen Dollar, die eine finanzielle Stabilität bis Mitte 2026 gewährleistet. Das Unternehmen erhielt die CTA-Genehmigungen für die Phase-2-Studie von RLYB212, wobei das Screening für das vierte Quartal 2024 erwartet wird. Die F&E-Ausgaben sanken auf 8,2 Millionen Dollar von 13,3 Millionen Dollar, während die allgemeinen und Verwaltungskosten auf 4,1 Millionen Dollar von 6,1 Millionen Dollar im Jahresvergleich reduziert wurden, hauptsächlich aufgrund von Personalabbau und niedrigeren Entwicklungskosten.

Positive
  • Received CTA approvals for RLYB212 Phase 2 clinical trial
  • Reduced net loss by 37.5% year-over-year
  • Cash runway extended into mid-2026
  • Generated first revenue of $0.3 million from Johnson & Johnson collaboration
  • Decreased R&D expenses by 38.3%
  • Reduced G&A expenses by 32.8%
Negative
  • Continued net loss of $11.5 million in Q3 2024
  • Workforce reduction implemented to cut costs

Insights

The Q3 results show a significant financial improvement with reduced cash burn. Key metrics include: $75.1M cash position providing runway into mid-2026, reduced R&D expenses to $8.2M from $13.3M YoY and lower G&A expenses at $4.1M vs $6.1M. Net loss improved to $11.5M ($0.26/share) from $18.4M ($0.45/share). The company's cost-cutting initiatives and focused investment strategy are yielding results, though revenue remains minimal at $0.3M.

The extended cash runway and strategic partnerships (J&J collaboration) provide financial stability for key clinical milestones through 2025. However, with a small market cap of $42.9M, additional financing may be needed for late-stage development.

The advancement of RLYB212 into Phase 2 trials for FNAIT prevention represents a significant milestone. The epidemiological analysis revealing 30,000 high-risk pregnancies annually in North America and major European markets defines a clear target population. The successful CTA approvals from both EMA and MHRA, coupled with 13,000+ pregnant women screened in the natural history study, demonstrate strong clinical development progress.

The RLYB116 program shows promise beyond its initial target indication, with potential applications in PNH and antiphospholipid syndrome. The manufacturing improvements and complement biomarker characterization suggest enhanced therapeutic potential, though detailed efficacy data is pending December updates.

CTA Approvals Received for RLYB212 Phase 2 Clinical Trial; On Track to Initiate Screening in 4Q 2024

$75.1 Million in Cash, Cash Equivalents, and Marketable Securities as of September 30, 2024 Provides Runway into Mid-2026

NEW HAVEN, Conn.--(BUSINESS WIRE)-- Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported third quarter financial results for the period ended September 30, 2024, and provided an update on recent company developments.

“Advancing RLYB212 into a Phase 2 trial marks a significant achievement for Rallybio. With clinical trial application (CTA) approvals in-hand, our team is activating clinical sites, and we expect to initiate screening for pregnant women at higher risk for alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in the coming weeks,” said Stephen Uden, M.D., Chief Executive Officer of Rallybio. “Additionally, the focused investments in our RLYB116 program have delivered important data that we look forward to sharing in December along with next steps for the program. As a result of our refocused operating plan announced earlier this year, we have reduced our cash burn and we are on track to achieve all of our 2024 pipeline milestones. We will continue our strategy of focused investments which positions Rallybio to deliver multiple key value inflection points in 2025 and long-term value creation.”

Recent Business Highlights and Upcoming Milestones:

RLYB212 Program

  • Rallybio announced the approval of its CTAs for the RLYB212 Phase 2 dose confirmation trial in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT. With these approvals from the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), activation of clinical sites is underway and screening is on track to begin in the fourth quarter of 2024.
  • Screening continues in the Company's FNAIT natural history study, with more than 13,000 pregnant women screened as of November 1, 2024. Rallybio has now transitioned European sites from the natural history study to the Phase 2 trial, where the sites will continue to collect natural history data in those women at higher risk for HPA-1a alloimmunization who do not receive RLYB212.
  • Results from the Phase 1b proof-of-concept study were published in Thrombosis and Haemostasis in August 2024. Additional publications, including the rationale and modeling that support the RLYB212 Phase 2 dose regimen, are expected later this year.
  • Data from a preclinical model demonstrating that prophylactic administration of RLYB212 safely and effectively prevents FNAIT in pregnant mice will be presented at the American Society of Hematology (ASH) Annual Meeting being held December 7 – 10 in San Diego, CA.

Title: Prophylactic Administration of HPA-1a–Specific Antibody RLYB212 Safely Prevents Fetal/Neonatal Alloimmune Thrombocytopenia in Pregnant Mice
Publication Number: 1185
Session Name: 311. Disorders of Platelet Number or Function: Clinical and Epidemiological: Poster I
Session Date: Saturday, December 7, 2024
Presentation Time: 5:30 PM - 7:30 PM
Location: San Diego Convention Center, Halls G-H

This poster was also selected for the ASH Poster Walk on Hemostasis and Thrombosis: from Basic Concepts to Clinical Applications Hosted by Blood Vessels, Thrombosis & Hemostasis, which will take place on December 7 from 11:15 AM - 12:15 PM.

  • Rallybio presented full data from an epidemiological analysis that provided the first robust evidence quantifying the proportion of women of non-Caucasian ancestries that carry the genetic markers for higher FNAIT risk (HPA-1a negative, HLA-DRB3*01:01 positive) at the NORD Rare Diseases and Orphan Products Breakthrough Summit, which was held October 20 – 22 in Washington D.C., and at the American Society of Human Genetics (ASHG) Annual Meeting, which is being held November 5 – 9 in Denver, CO. Based on the data, it is estimated that more than 30,000 pregnancies each year are at higher risk for FNAIT in North America and major European countries alone.

RLYB116 Program

  • RLYB116 manufacturing work was successfully completed in the third quarter of 2024. Rallybio expects that the process enhancements from this manufacturing work will improve the tolerability of RLYB116.
  • Additional complement biomarker characterization has been completed. These results, when taken together with Phase 1 MAD data, indicate that RLYB116 led to greater sustained reductions in free C5 than initially understood. Based on these analyses, Rallybio believes that there is an opportunity to pursue indications beyond generalized myasthenia gravis, including paroxysmal nocturnal hemoglobinuria and antiphospholipid syndrome at doses tested in the Phase 1 MAD study.
  • In December 2024, Rallybio expects to provide updates on the manufacturing process enhancements and biomarker characterization as well as future plans for RLYB116.

Preclinical Programs

In accordance with its 2024 operating plan, Rallybio is advancing its preclinical programs to important 2024 milestones. Beyond achievement of these milestones, Rallybio is seeking alternative options to further advance these programs, including partnerships and other forms of non-dilutive financing.

  • RLYB332: Nonclinical data evaluating RLYB332, a long-acting version of the RLYB331 anti-matriptase-2 antibody, will be presented at the upcoming ASH Annual Meeting.

Title: Long-Acting Anti-Matriptase-2 Antibody as a Potentially Best-in-Class Therapy for Iron Overload Diseases
Publication Number: 3854
Session Name: 102. Iron Homeostasis and Biology: Poster III
Session Date: Monday, December 9, 2024
Presentation Time: 6:00 PM - 8:00 PM
Location: San Diego Convention Center, Halls G-H

  • ENPP1 Inhibitor, Exscientia Partnership: Rallybio and Exscientia remain on track to nominate an ENPP1 inhibitor development candidate for the treatment of patients with hypophosphatasia (HPP) in December 2024. Data from an early lead ENPP1 inhibitor in a model of HPP was presented at the American Society for Bone and Mineral Research (ASBMR) meeting in September. The data demonstrated that oral dosing of REV101 to adult HPP mice lowered inorganic pyrophosphate (PPi) by 30%, leading to improvements in mineralization of long and vertebrate bones. Furthermore, data showed that ENPP1 inhibition was safe and well-tolerated. Data also showed, for the first time, that ENPP1 is a druggable target for later-onset HPP.

Corporate Updates

  • Rallybio was named to the 2024 Fierce 50 List as an Innovation Honoree.

Third Quarter 2024 Financial Results

  • Revenue: Revenue was $0.3 million for the third quarter of 2024, compared to no revenue in the same period in 2023. The increase was related to Rallybio's entrance into the collaboration agreement with Johnson & Johnson in the second quarter of 2024 and the recognition of revenue related to the collaboration's performance obligations.
  • Research & Development (R&D) Expenses: R&D expenses were $8.2 million for the third quarter of 2024, compared to $13.3 million for the same period in 2023. The decrease in R&D expense was primarily due to a decrease in development costs related to RLYB116 and RLYB212, in addition to a decrease in payroll and personnel-related costs, largely related to the workforce reduction and lower ongoing headcount in 2024 as compared to 2023.
  • General & Administrative (G&A) Expenses: G&A expenses were $4.1 million for the third quarter of 2024, compared to $6.1 million for the same period in 2023. The decrease in G&A expense was primarily related to lower payroll and personnel-related costs, largely related to the workforce reduction and lower ongoing headcount in 2024 as compared to 2023, and reductions in other related general and administrative expenses, including a reduction in consulting fees.
  • Net Loss and Net Loss Per Common Share: Rallybio reported a net loss of $11.5 million, or $0.26 per common share, for the third quarter of 2024. This compares to a net loss of $18.4 million, or $0.45 per common share, for the third quarter of 2023.
  • Cash Position: As of September 30, 2024, cash, cash equivalents, and marketable securities were $75.1 million.

About Rallybio
Rallybio (NASDAQ: RLYB) is a clinical-stage biotechnology company with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Rallybio has built a broad pipeline of promising product candidates aimed at addressing diseases with unmet medical need in areas of maternal fetal health, complement dysregulation, hematology, and metabolic disorders. The Company has two clinical stage programs: RLYB212, an anti-HPA-1a antibody for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT) and RLYB116, an inhibitor of complement component 5 (C5), with the potential to treat several diseases of complement dysregulation, as well as additional programs in preclinical development. Rallybio is headquartered in New Haven, Connecticut. For more information, please visit www.rallybio.com and follow us on LinkedIn and Twitter.

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. All statements, other than statements of historical facts contained in this press release are forward-looking statements. 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 the timing of initiation of the Phase 2 clinical trial for RLYB212, whether the results of the FNAIT natural history study and the planned RLYB212 Phase 2 trial will be sufficient to support design and implementation of a Phase 3 registrational study for RLYB212, whether the manufacturing work for RLYB116 will result in improved tolerability, if and when tested in a clinical trial, our expectations regarding the usefulness of data from our clinical studies, our expectations regarding driving awareness of FNAIT through the Johnson & Johnson collaboration, our ability to more accurately identify the number of pregnant women at higher risk of FNAIT and our estimates of the number of women at higher risk for FNAIT in North America and major European countries alone, our estimates of the market opportunity for RLYB212, the timing of publications relating to FNAIT and RLYB212, whether our conclusions from RLYB116 biomarker characterization work will be informative, the timing of achieving milestones in 2024 for our preclinical programs, including for candidate nomination of an ENPP1 inhibitor, whether Rallybio will deliver multiple key value inflection points in 2025, if any, and long-term value creation, the likelihood that Rallybio will be successful in developing RLYB212, RLYB116, or any of our other product candidates, our ability to successfully identify and implement alternative and acceptable options to further advance our programs, our estimates of our capital requirements and the sufficiency thereof, and our cash runway. 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 2 trial for RLYB212, 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 enter into strategic partnerships or other arrangements, 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 Quarterly Report on Form 10-Q for the period ended June 30, 2024, 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.

Financial Tables

RALLYBIO CORPORATION
SELECTED CONDENSED CONSOLIDATED FINANCIAL INFORMATION

Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)

 

FOR THE THREE MONTHS ENDED
SEPTEMBER 30,

 

FOR THE NINE MONTHS ENDED
SEPTEMBER 30,

(in thousands, except share and per share amounts)

2024

 

2023

 

2024

 

2023

Revenue:

 

 

 

 

 

 

 

Collaboration and license revenue

$

299

 

 

$

 

 

$

598

 

 

$

 

Total revenue

 

299

 

 

 

 

 

 

598

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

 

8,240

 

 

 

13,288

 

 

 

34,122

 

 

 

37,620

 

General and administrative

 

4,125

 

 

 

6,075

 

 

 

15,364

 

 

 

20,200

 

Total operating expenses

 

12,365

 

 

 

19,363

 

 

 

49,486

 

 

 

57,820

 

Loss from operations

 

(12,066

)

 

 

(19,363

)

 

 

(48,888

)

 

 

(57,820

)

Other income:

 

 

 

 

 

 

 

Interest income

 

986

 

 

 

1,545

 

 

 

3,405

 

 

 

4,699

 

Other income

 

251

 

 

 

92

 

 

 

561

 

 

 

227

 

Total other income, net

 

1,237

 

 

 

1,637

 

 

 

3,966

 

 

 

4,926

 

Loss before equity in losses of joint venture

 

(10,829

)

 

 

(17,726

)

 

 

(44,922

)

 

 

(52,894

)

Loss on investment in joint venture

 

637

 

 

 

648

 

 

 

1,809

 

 

 

1,428

 

Net loss

$

(11,466

)

 

$

(18,374

)

 

$

(46,731

)

 

$

(54,322

)

 

 

 

 

 

 

 

 

Net loss per common share, basic and diluted

$

(0.26

)

 

$

(0.45

)

 

$

(1.08

)

 

$

(1.35

)

Weighted-average common shares outstanding, basic and diluted

 

44,593,221

 

 

 

40,531,497

 

 

 

43,170,177

 

 

 

40,382,625

 

 

 

 

 

 

 

 

 

Other comprehensive loss:

 

 

 

 

 

 

 

Net unrealized gain (loss) on marketable securities

 

240

 

 

 

64

 

 

 

154

 

 

 

6

 

Other comprehensive gain (loss)

 

240

 

 

 

64

 

 

 

154

 

 

 

6

 

Comprehensive loss

$

(11,226

)

 

$

(18,310

)

 

$

(46,577

)

 

$

(54,316

)

Condensed Consolidated Balance Sheets
(Unaudited)

(in thousands)

SEPTEMBER 30,
2024

 

DECEMBER 31,
2023

Cash, cash equivalents and marketable securities

$

75,139

 

$

109,929

Total assets

 

79,007

 

 

115,620

Total liabilities

 

8,189

 

 

9,436

Total stockholders' equity

 

70,818

 

 

106,184

 

Investors

Samantha Tracy

Rallybio Corporation

(475) 47-RALLY (Ext. 282)

investors@rallybio.com



Kevin Lui

Precision AQ

(212) 698-8691

Kevin.Lui@precisionaq.com



Media

Victoria Reynolds

Mission North

(760) 579-2134

rallybio@missionnorth.com

Source: Rallybio Corporation

FAQ

What was Rallybio's (RLYB) net loss in Q3 2024?

Rallybio reported a net loss of $11.5 million, or $0.26 per share, in Q3 2024.

How much cash does Rallybio (RLYB) have as of September 30, 2024?

Rallybio had $75.1 million in cash, cash equivalents, and marketable securities as of September 30, 2024.

When will Rallybio (RLYB) begin screening for the RLYB212 Phase 2 trial?

Rallybio is on track to begin screening for the RLYB212 Phase 2 trial in Q4 2024.

What was Rallybio's (RLYB) revenue in Q3 2024?

Rallybio reported revenue of $0.3 million in Q3 2024, related to their collaboration agreement with Johnson & Johnson.

Rallybio Corporation

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