rlyb-20240930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

_____________________________________

FORM 10-Q

_____________________________________

(Mark One)


x			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024


o			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______________ to ______________

Commission File Number: 001-40693

_____________________________________

RALLYBIO CORPORATION

(Exact Name of Registrant as Specified in its Charter)

_____________________________________


Delaware			85-1083789
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification No.)
234 Church Street, Suite 1020 New Haven, CT			06510
(Address of principal executive offices)			(Zip Code)

Registrant’s telephone number, including area code: (203) 859-3820

_____________________________________

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

RLYB

The NASDAQ Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	o	Accelerated filer	o
Non-accelerated filer	x	Smaller reporting company	x
		Emerging growth company	x

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. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes x No o

As of November 4, 2024, the registrant had 41,487,586 shares of common stock, $0.0001 par value per share, outstanding.

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		Page
PART I.	FINANCIAL INFORMATION
Item 1.	Financial Statements	7
	Unaudited Condensed Consolidated Balance Sheets	7
	Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss	8
	Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity	9
	Unaudited Condensed Consolidated Statements of Cash Flows	10
	Notes to Unaudited Condensed Consolidated Financial Statements	11
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	33
Item 4.	Controls and Procedures	33

PART II.	OTHER INFORMATION
Item 1.	Legal Proceedings	35
Item 1A.	Risk Factors	35
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	89
Item 5.	Other Information	90
Item 6.	Exhibits	91
Signatures		92

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Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements 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 include, but are not limited to, statements concerning:

•the initiation, timing, progress, results, and cost of our research and development programs, and our current and future preclinical and clinical studies, including statements regarding the timing of initiation and completion of our clinical trials for RLYB212, RLYB116, and the natural history study for our fetal and neonatal alloimmune thrombocytopenia prevention program, and related preparatory work, and the period during which the results of the trials will become available;

•the success, cost and timing of the clinical development of our product candidates, including RLYB212 and RLYB116;

•the potential of our product candidates to treat certain target diseases;

•our ability to initiate, recruit and enroll patients in and conduct our clinical trials at the pace that we project;

•our ability to obtain and maintain regulatory designations allowing for priority review of our product candidates, and our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations or warnings in the label of any of our product candidates, if approved;

•our ability to compete with companies currently marketing or engaged in the development of treatments for diseases that our product candidates are designed to target, including paroxysmal nocturnal hemoglobinuria and generalized myasthenia gravis;

•our reliance on third parties to conduct our clinical trials;

•enhancements to the manufacturing process for RLYB116;

•our reliance on third parties to manufacture drug substance and drug product for use in our clinical trials;

•the size and growth potential of the markets for RLYB212, RLYB116, RLYB114, RLYB332 and any of our current product candidates or other product candidates we may identify and pursue, and our ability to serve those markets;

•our ability to identify and advance through clinical development any additional product candidates;

•the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build commercial infrastructure or enter into collaborations with third parties to market our current product candidates and any other product candidates we may identify and pursue;

•our ability to retain and recruit key personnel;

•our ability to obtain and maintain adequate intellectual property rights;

•our expectations regarding government and third-party payor coverage and reimbursement;

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•our estimates of our expenses, ongoing losses, capital requirements and our needs for or ability to obtain additional financing;

•our expected uses of the net proceeds from our initial public offering and any subsequent offerings;

•the potential benefits of strategic collaboration agreements and arrangements, including our agreements with Johnson & Johnson, Exscientia Limited and AbCellera Biologics Inc. and our research collaboration with EyePoint Pharmaceuticals, Inc., and the expected timing of updates related thereto, including timing to achieve development candidate nominations, our ability to enter into strategic collaborations or arrangements, including potential business development opportunities and potential licensing partnerships, and our ability to attract collaborators with development, regulatory and commercialization expertise;

•our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012;

•our financial performance;

•developments and projections relating to our competitors or our industry; and

•other risks and uncertainties, including those listed under the section titled “Risk Factors.”

The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of known and unknown risks, uncertainties and assumptions, including those described under the sections in this Quarterly Report on Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as guarantees of future events. 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. Moreover, we operate in an evolving environment. New risks and uncertainties may emerge from time to time, and it is not possible for management to predict all risks and uncertainties. Except as required by applicable law, we are not obligated to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Trademarks

We use Rallybio as a trademark in the United States ("U.S.") and/or in other countries. This Quarterly Report on Form 10-Q contains references to our trademark and to those belonging to other entities, including Affibody®. Solely for convenience, trademarks and trade names referred to in this Quarterly Report on Form 10-Q, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other entities’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entity.

Risk Factor Summary

Our business is subject to a number of risks that are discussed more fully in the “Risk Factors” section of this Quarterly Report on Form 10-Q. These risks include the following:

•We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the foreseeable future. We have not commercialized any products and have never generated revenue from the commercialization of any product. We are not currently profitable, and we may never achieve or sustain profitability;

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•We will require significant additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of RLYB212, RLYB116 or any additional product candidates we may develop;

•Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates;

•We are heavily dependent on the success of RLYB212 and RLYB116, which are in early-stage clinical development. If we are not able to develop, obtain regulatory approval for, or successfully commercialize our product candidates, or if we experience significant delays in doing so, our business will be materially harmed;

•We may not be successful in our efforts to identify additional product candidates. Due to our limited resources and access to capital, we must prioritize development of certain product candidates, the choice of which may prove to be wrong and adversely affect our business;

•Preclinical studies and clinical trials are expensive, time consuming and difficult to design and implement, and involve uncertain outcomes. Any product candidates that we advance into clinical trials may not achieve favorable results in later clinical trials, if any, or receive marketing approval. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates;

•Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, including our focus on rare diseases;

•Results of preclinical studies, clinical trials or analyses that we may announce or publish from time to time, may not be indicative of results obtained in later trials, and any interim results we may publish could be different than final results;

•Any product candidates that we develop or the administration thereof, may cause serious adverse events or undesirable side effects, which may halt their clinical development, delay or prevent marketing approval, or, if approved, require them to be taken off the market, include safety warnings, or otherwise limit their sales;

•The regulatory approval processes of the U.S. Food and Drug Administration (the "FDA"), the European Medicines Agency (the "EMA"), and comparable foreign regulatory authorities, including the Medicines and Healthcare products Regulatory Agency in the United Kingdom (the “MHRA”), are lengthy, time-consuming, and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for RLYB212, RLYB116 or any of our other product candidates, our business will be substantially harmed;

•Our product candidates target rare diseases and conditions, and the market opportunities for RLYB212, RLYB116 or any of our other product candidates, if approved, may be smaller than we anticipate. As a result, our commercial opportunity may be limited and because the target populations of our product candidates are for rare diseases, we must be able to successfully identify patients and capture a significant market share to achieve profitability and growth;

•The FDA, EMA or other comparable foreign regulatory authorities, including the MHRA, could require the clearance or approval of an in vitro diagnostic or companion diagnostic device as a condition of approval for any product candidate that requires or would commercially benefit from such tests, including RLYB212. Failure to successfully validate, develop and obtain regulatory clearance or approval for companion diagnostics on a timely basis or at all could harm our drug development strategy and we may not realize the commercial potential of any such product candidate;

•We face significant competition from biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively;

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•We intend to continue to pursue business development transactions focused on the in-license of additional product candidates or the out-license of rights to product candidates in our pipeline and collaborate with third parties for the development and commercialization of our product candidates. We may not succeed in identifying and acquiring businesses or assets, in-licensing intellectual property rights or establishing and maintaining collaborations, which may significantly limit our ability to successfully develop and commercialize our other product candidates, if at all, and these transactions could disrupt our business, cause dilution to our stockholders or reduce our financial resources; and

•If we are unable to obtain, maintain and enforce patent protection for our technology and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology and product candidates may be adversely affected.

The foregoing is only a summary of some of our risks. For a more detailed discussion of these and other risks you should consider before making an investment in our common stock, see “Risk Factors.”

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PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

RALLYBIO CORPORATION

Condensed Consolidated Balance Sheets

(Unaudited)


(in thousands, except share and per share amounts)	SEPTEMBER 30, 2024		DECEMBER 31, 2023
Assets
Current assets:
Cash and cash equivalents	$	25,320	$	24,494
Marketable securities	49,819		85,435
Prepaid expenses and other current assets	3,091		4,860
Total current assets	78,230		114,789
Property and equipment, net	145		246
Operating lease right-of-use assets	201		346
Investment in joint venture	431		239
Total assets	$	79,007	$	115,620
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	583	$	976
Accrued expenses	6,279		8,068
Operating lease liabilities	230		219
Deferred revenue	1,097		—
Total current liabilities	8,189		9,263
Operating lease liabilities, noncurrent	—		173

Total liabilities	8,189		9,436
Commitments and contingencies (Note 7)
Stockholders' equity
Common stock, $0.0001 par value per share; 200,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively; and 41,487,586 and 37,829,565 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively	4		4
Preferred stock, $0.0001 par value per share; 50,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively; no shares issued or outstanding as of September 30, 2024 and December 31, 2023, respectively	—		—
Additional paid-in capital	352,621		341,410
Accumulated other comprehensive loss	169		15
Accumulated deficit	(281,976)		(235,245)
Total stockholders' equity	70,818		106,184
Total liabilities and stockholders' equity	$	79,007	$	115,620

See accompanying notes of the condensed consolidated financial statements

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RALLYBIO CORPORATION

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)

See accompanying notes of the condensed consolidated financial statements

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RALLYBIO CORPORATION

Condensed Consolidated Statements of Changes in Stockholders' Equity

(Unaudited)


FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023	COMMON			ADDITIONAL PAID-IN CAPITAL		ACCUMULATED DEFICIT		ACCUMULATED OTHER COMPREHENSIVE GAIN (LOSS)		STOCKHOLDERS' EQUITY
(in thousands, except share amounts)	SHARES	AMOUNT
June 30, 2023	37,790,856	$	4	$	336,154	$	(196,629)	$	(272)	$	139,257
Share-based compensation expense	—	—		2,634		—		—		2,634


Issuance of common stock under the stock award plan	10,000	—		—		—		—		—

Net loss	—	—		—		(18,374)		—		(18,374)
Other comprehensive gain	—	—		—		—		64		64
Balance, September 30, 2023	37,800,856	$	4	$	338,788	$	(215,003)	$	(208)	$	123,581

June 30, 2024	41,487,586	$	4	$	350,594	$	(270,510)	$	(71)	$	80,017
Share-based compensation expense	—	—		2,027		—		—		2,027




Net loss	—	—		—		(11,466)		—		(11,466)
Other comprehensive gain	—	—		—		—		240		240
Balance, September 30, 2024	41,487,586	$	4	$	352,621	$	(281,976)	$	169	$	70,818


FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023	COMMON			ADDITIONAL PAID-IN CAPITAL		ACCUMULATED DEFICIT		ACCUMULATED OTHER COMPREHENSIVE GAIN (LOSS)		STOCKHOLDERS' EQUITY
(in thousands, except share amounts)	SHARES	AMOUNT
December 31, 2022	37,837,369	$	4	$	330,208	$	(160,681)	$	(214)	$	169,317
Share-based compensation expense	—	—		8,371		—		—		8,371
Issuance of common stock under the stock award plan	11,219	—		—		—		—		—
Issuance of common stock under the stock purchase plan	43,423	—		209		—		—		209
Forfeiture of restricted common stock	(91,155)	—		—		—		—		—
Net loss	—	—		—		(54,322)		—		(54,322)
Other comprehensive gain	—	—		—		—		6		6
Balance, September 30, 2023	37,800,856	$	4	$	338,788	$	(215,003)	$	(208)	$	123,581

December 31, 2023	37,829,565	$	4	$	341,410	$	(235,245)	$	15	$	106,184
Share-based compensation expense	—	—		6,030		—		—		6,030
Issuance of common stock upon completion of a securities purchase agreement, net of offering costs of $268	3,636,363	—		5,137		—		—		5,137
Issuance of common stock under the stock award plan	1,925	—		—		—		—		—
Issuance of common stock under the stock purchase plan	38,289	—		44		—		—		44
Forfeiture of restricted common stock	(18,556)	—		—		—		—		—
Net loss	—	—		—		(46,731)		—		(46,731)
Other comprehensive gain	—	—		—		—		154		154
Balance, September 30, 2024	41,487,586	$	4	$	352,621	$	(

SEC Form 10-Q filed by Rallybio Corporation