UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On September 9, 2021, Rallybio Corporation issued a press release announcing its financial results for the quarter ended June 30, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
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(d) Exhibits |
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Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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RALLYBIO CORPORATION |
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Date: |
September 9, 2021 |
By: |
/s/ Jeffrey M. Fryer |
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Jeffrey M. Fryer, CPA |
Exhibit 99.1
Rallybio Corporation Reports Second Quarter 2021 Financial Results and Recent Business Highlights
̶ Completed initial public offering for $92.7 million of gross proceeds ̶
̶ Clinical proof-of-concept data for RLYB211 for the prevention of FNAIT was presented at the ISTH Virtual Congress; Additional Phase 1/2 data expected in 4Q 2021 ̶
̶ On-track to initiate Phase 1 studies of RLYB212, in development for the prevention of FNAIT, and RLYB116, in development for the treatment of patients with PNH and gMG, in 1Q 2022 ̶
New Haven, Conn. -- September 9, 2021 -- 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 its financial results for the second quarter ended June 30, 2021 and provided an update on recent corporate developments.
“Since our founding in 2018, Rallybio has made consistent progress towards achieving our mission to truly transform the lives of patients with severe and rare diseases. With a tremendous team, we have now built a diversified portfolio of five programs, and we continue to work expeditiously to advance our pipeline,” said Martin Mackay, Ph.D., Chief Executive Officer of Rallybio. “Following the closing of our initial public offering in early August, we are operating from a position of financial strength, and we are poised to build on this momentum in the months ahead, with additional Phase 1/2 data for RLYB211 expected before year end, and the initiation of Phase 1 studies of RLYB212 and RLYB116 both planned for the first quarter of 2022.”
Rallybio’s current pipeline is focused on addressing diseases in the areas of hematology, immuno-inflammation, maternal fetal health, and metabolic disorders.
Recent 2021 Business Highlights:
Upcoming Milestones:
Second Quarter and First Half 2021 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, the initiation and timing of our planned clinical trials, including our clinical trials for RLYB212, and RLYB116, and the natural history study for our FNAIT
prevention program, and the period during which the results of the trials will become available or announced. 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 clinical trials for RLYB212 and 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, 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 final prospectus for its initial public offering dated July 28, 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.
Financial Tables
RALLYBIO HOLDINGS, LLC AND SUBSIDIARIES(1)
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
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THREE MONTHS ENDED |
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SIX MONTHS ENDED |
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(in thousands, except units and per unit amounts) |
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2021 |
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2020 |
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2021 |
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2020 |
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Operating Expenses: |
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Research and development |
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$ |
6,818 |
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$ |
3,092 |
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$ |
15,855 |
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$ |
5,005 |
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General and administrative |
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3,712 |
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1,570 |
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7,499 |
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3,501 |
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Total operating expenses |
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10,530 |
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4,662 |
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23,354 |
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8,506 |
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Loss from operations |
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(10,530 |
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(4,662 |
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(23,354 |
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(8,506 |
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Other income (expenses): |
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Interest income |
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13 |
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47 |
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30 |
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102 |
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Interest expense |
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— |
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(12 |
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(10 |
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(24 |
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Other (expense) income |
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(142 |
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69 |
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(118 |
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121 |
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Total other (expense) income, net |
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(129 |
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104 |
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(98 |
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199 |
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Loss before income taxes |
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(10,659 |
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(4,558 |
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(23,452 |
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(8,307 |
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Income tax benefit |
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— |
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— |
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— |
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(16 |
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Loss on investment in joint venture |
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468 |
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335 |
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950 |
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483 |
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Net loss and comprehensive loss |
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$ |
(11,127 |
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$ |
(4,893 |
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$ |
(24,402 |
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$ |
(8,774 |
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Net loss attributable to common units |
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$ |
(11,127 |
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$ |
(4,893 |
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$ |
(24,402 |
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$ |
(8,774 |
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Net loss per common unit, basic and diluted (2) |
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$ |
(2.80 |
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$ |
(1.85 |
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$ |
(6.77 |
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$ |
(3.81 |
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Weighted average common units outstanding, basic and diluted (2) |
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3,978,054 |
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2,643,750 |
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3,603,193 |
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2,304,385 |
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RALLYBIO HOLDINGS, LLC AND SUBSIDIARIES(1)
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands) |
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JUNE 30, |
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DECEMBER 31, |
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Cash and cash equivalents |
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$ |
112,729 |
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$ |
140,233 |
Total assets |
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$ |
120,097 |
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$ |
141,858 |
Total liabilities |
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$ |
7,435 |
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$ |
5,855 |
Total members’ deficit |
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$ |
(69,365 |
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$ |
(46,024) |
Total liabilities, redeemable convertible preferred units, and members’ deficit |
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$ |
120,097 |
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$ |
141,858 |
Investor Contacts
Steven Tuch
investors@rallybio.com
Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
hannah.deresiewicz@sternir.com
Media Contact
Tara DiMilia
908-369-7168
Tara.dimilia@tmstrat.com
Document and Entity Information |
Sep. 09, 2021 |
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Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Sep. 09, 2021 |
Trading Symbol | RLYB |
Entity Registrant Name | RALLYBIO CORPORATION |
Entity Central Index Key | 0001739410 |
Entity Incorporation, State or Country Code | DE |
Entity File Number | 001-40693 |
Entity Tax Identification Number | 85-1083789 |
Entity Address, Address Line One | 234 Church Street |
Entity Address, Address Line Two | Suite 1020 |
Entity Address, City or Town | New Haven |
Entity Address, State or Province | CT |
Entity Address, Postal Zip Code | 06510 |
City Area Code | 203 |
Local Phone Number | 859-3820 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Common Stock, par value $0.0001 per share |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | true |
Entity Ex Transition Period | false |
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