Day One Reports Second Quarter 2024 Financial Results and Corporate Progress

Rhea-AI Summary

Day One Biopharmaceuticals (Nasdaq: DAWN) reported strong Q2 2024 results, highlighted by $8.2 million in OJEMDATM (tovorafenib) net product revenues in its initial 2 months of launch. The company expanded its pipeline with DAY301, a potential first-in-class Antibody Drug Conjugate targeting PTK7. Day One entered into an exclusive licensing agreement with Ipsen to commercialize tovorafenib outside the U.S. for approximately $111 million upfront in cash and equity investment. The company also secured an oversubscribed private placement for total gross proceeds of about $175 million.

Financial highlights include a cash position of $361.9 million as of June 30, 2024. R&D expenses increased to $92.1 million, primarily due to a $55 million upfront payment for the MabCare Therapeutics license agreement. Net loss for Q2 2024 was $4.4 million, compared to $45.9 million in Q2 2023.

Positive

• Achieved $8.2 million in OJEMDATM net product revenues in initial 2 months of launch
• Entered exclusive licensing agreement with Ipsen for $111 million upfront and potential $350 million in milestones
• Secured oversubscribed private placement for $175 million gross proceeds
• Sold rare pediatric disease Priority Review Voucher for $108 million
• Cash position of $361.9 million as of June 30, 2024
• Reduced net loss to $4.4 million in Q2 2024 from $45.9 million in Q2 2023

Negative

• R&D expenses increased to $92.1 million from $32.2 million year-over-year
• SG&A expenses rose to $30.2 million from $17.1 million year-over-year
• Closed pimasertib program, including FIRELIGHT-1 trial

Insights

Financial Analyst

Day One Biopharmaceuticals' Q2 2024 results reveal a strong financial position and significant progress in their commercial launch and pipeline development. The company reported $8.2 million in net product revenues from OJEMDA in just two months post-launch, indicating robust initial demand. This early success is promising for future revenue growth.

The company's cash position of $361.9 million as of June 30, 2024, bolstered by a $175 million private placement and $108 million from the sale of a Priority Review Voucher, provides substantial runway for ongoing operations and pipeline advancement. However, investors should note the increased R&D expenses ($92.1 million vs $32.2 million in Q2 2023), primarily due to a $55 million upfront payment for the MabCare Therapeutics license agreement.

The licensing deal with Ipsen, potentially worth up to $461 million including milestones, plus double-digit royalties, significantly enhances Day One's commercial reach and future revenue potential. This partnership strategy could prove important for maximizing OJEMDA's market penetration globally.

While the net loss of $4.4 million is a substantial improvement from $45.9 million in Q2 2023, it's important to recognize that this includes non-recurring gains. Ongoing SG&A expenses increased to $30.2 million, reflecting the company's investment in commercial infrastructure.

Overall, Day One's financial performance and strategic moves suggest a company transitioning effectively from development to commercialization, with a strong balance sheet to support future growth.

Oncology Expert

Day One's OJEMDA (tovorafenib) represents a significant advancement in the treatment of pediatric low-grade glioma (pLGG), being the first FDA-approved therapy for this indication. The updated data from the FIREFLY-1 trial, showing a median treatment duration of 23.7 months, with some patients continuing treatment up to 32 months, is particularly encouraging. This extended treatment duration suggests durable efficacy and tolerability, critical factors in pediatric oncology.

The expansion of Day One's pipeline with DAY301, an Antibody Drug Conjugate (ADC) targeting PTK7, is a strategic move into a cutting-edge area of oncology. ADCs have shown promise in various cancers due to their ability to deliver cytotoxic payloads directly to tumor cells, potentially improving efficacy while reducing systemic toxicity. The PTK7 target is intriguing, as it's involved in Wnt signaling and cell polarity, processes often dysregulated in cancer.

The decision to close the pimasertib program, while disappointing, demonstrates the company's willingness to make tough decisions and reallocate resources to more promising avenues. This agility is important in the fast-paced oncology drug development landscape.

The ongoing FIREFLY-2/LOGGIC trial, evaluating tovorafenib as a front-line therapy, could significantly expand the drug's market potential if successful. Front-line approval would position OJEMDA as a standard of care in pLGG, potentially capturing a larger patient population.

Overall, Day One's focus on targeted therapies for pediatric cancers addresses a critical unmet need in oncology, positioning the company as a potential leader in this niche but important market.

Market Research Analyst

Day One's Q2 2024 results and recent developments paint a picture of a company rapidly establishing itself in the pediatric oncology market. The $8.2 million in net product revenues for OJEMDA in just two months post-launch suggests strong market acceptance and potentially rapid uptake. This is particularly impressive given the challenges often associated with launching drugs for rare pediatric indications.

The licensing agreement with Ipsen for ex-U.S. commercialization of tovorafenib is a strategic masterstroke. It not only provides immediate capital ($111 million upfront) but also leverages Ipsen's global commercial infrastructure, potentially accelerating OJEMDA's market penetration worldwide. The deal structure, with up to $350 million in additional milestones and double-digit royalties, aligns both companies' interests in maximizing the drug's commercial potential.

The addition of DAY301 to the pipeline diversifies Day One's portfolio and could open up new market opportunities beyond pLGG. The ADC market is projected to grow significantly in the coming years and a first-in-class ADC targeting PTK7 could capture substantial market share if successful.

The closure of the pimasertib program, while potentially disappointing to some investors, demonstrates the company's commitment to efficient resource allocation. This decision allows Day One to focus on its most promising assets, potentially accelerating time-to-market for key programs.

The 100% increase in activated sites for the FIREFLY-2/LOGGIC trial indicates strong investigator interest and could lead to faster enrollment and earlier data readouts. If positive, these results could significantly expand OJEMDA's market opportunity in the front-line setting.

Overall, Day One's strategic moves and early commercial success position it well in the competitive oncology market, with potential for significant growth in the near to medium term.

Achieved $8.2 million in OJEMDA^TM (tovorafenib) net product revenues in initial 2 months of launch

Expanded pipeline with DAY301, potential first-in-class Antibody Drug Conjugate (ADC) targeting PTK7

Entered into exclusive licensing agreement with Ipsen to commercialize tovorafenib outside of the U.S. for approximately $111 million upfront in cash and equity investment at a premium

Entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175 million

Company to host conference call and webcast today, July 30, 8:00 a.m. Eastern Time

BRISBANE, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its second quarter 2024 financial results and highlighted recent corporate achievements.

“We had an outstanding quarter across all facets of our business,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “Demand for OJEMDA led to strong early launch performance following our first approval, and we made significant progress advancing our programs and pipeline, including the addition of DAY301, a potential first-in-class ADC targeting PTK7 that we expect to be in the clinic in the coming months.”

Program Highlights

• OJEMDA received U.S. Food and Drug Administration (FDA) accelerated approval in April 2024. It is the first and only FDA approved therapy for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
  
  
• Day One provided updated duration of treatment data from the registrational Phase 2 FIREFLY-1 trial investigating tovorafenib in patients with BRAF-altered, relapsed or progressive pLGG. For the 77 patients enrolled on Arm 1, which was the dataset used to assess OJEMDA’s efficacy, the median duration of treatment is now 23.7 months, with some patients being on treatment out to 32 months. Additional analyses will be presented at future medical conferences. 
  
  
• Day One and Ipsen entered into an exclusive licensing agreement to commercialize tovorafenib outside of the U.S. in July 2024. Under the agreement, Day One will receive approximately $111 million upfront in cash and equity investment at a premium with up to approximately $350 million in additional launch and sales milestone payments as well as tiered double-digit royalties starting in mid-teens percentage on net sales. Ipsen secured commercialization rights to tovorafenib outside of the U.S.
  
  
• Day One entered into an exclusive licensing agreement with MabCare Therapeutics for its novel ADC targeting protein-tyrosine kinase 7 (PTK7) in June 2024. The Company expects to dose the first patient in the Phase I portion of the Phase 1/2a clinical trial of DAY301 in the fourth quarter of 2024 or first quarter of 2025.
  
  
• Day One presented a poster on tovorafenib demonstrating reversibility of changes in growth velocity observed in the Phase 2 FIREFLY-1 clinical trial at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These data were also shared at the 21^st International Symposium on Pediatric Neuro-Oncology (ISPNO).
  
  
• Day One made the decision to close the pimasertib program in July 2024, including the FIRELIGHT-1 trial evaluating it in combination with tovorafenib. Resources will be redirected to the DAY301 program and results will be shared at a future medical meeting or publication.
  
  
• The pivotal Phase 3 FIREFLY-2/LOGGIC clinical trial evaluating tovorafenib as a front-line therapy in patients aged 6 months to 25 years with pLGG continues to enroll patients in the United States, Canada, Europe, Australia and Asia, with more than 100 sites activated.
  
  

Corporate Highlights and Upcoming Milestones

• Day One announced it entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175.0 million in July 2024.
  
  
• The Company sold the rare pediatric disease Priority Review Voucher awarded by the FDA upon OJEMDA’s approval for total cash proceeds of $108.0 million in May 2024, representing a gain on sale.
  
  
• Commercial operations veteran John Stubenrauch joined Day One in July 2024 as Chief Technology Officer. Dr. Stubenrauch, PhD, MBA, was most recently Chief Operating Officer at Nutcracker Therapeutics and brings more than 25 years of experience developing and commercializing medicines, including ADCs, as well as a broad range of product modalities.
  
  

Second Quarter 2024 Financial Highlights

• Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $361.9 million as of June 30, 2024.
  
  
• Product Revenue, Net: OJEMDA net product revenues were $8.2 million for the second quarter of 2024, the first partial quarter of the U.S. launch.
  
  
• R&D Expenses: Research and development expenses were $92.1 million for the second quarter of 2024 compared to $32.2 million for the second quarter of 2023. The increase was primarily due to the MabCare Therapeutics license agreement upfront payment of $55.0 million, increased clinical trial activities related to tovorafenib, and additional employee compensation costs.
  
  
• SG&A Expenses: Selling, general and administrative expenses were $30.2 million for the second quarter of 2024 compared to $17.1 million for the second quarter of 2023. The increase was primarily due to additional employee compensation costs, commercial launch activities, and increased professional service expenses to support company growth.
  
  
• Net Loss: Net loss totaled $4.4 million for the second quarter of 2024 with non-cash stock-based compensation expense of $13.0 million, compared to $45.9 million for the second quarter of 2023 with non-cash stock-based compensation expense of $9.5 million.
  
  

Upcoming Events

• 2024 Wedbush PacGrow Healthcare Conference, August 12-14, 2024
  
  

Conference Call

Day One will host a conference call and webcast today, July 30 at 8:00 a.m. Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Investors & Media page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30 days following the event.

About OJEMDA™
OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.

OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.

For more information, please visit www.ojemda.com.

About Day One Biopharmaceuticals
Day One Biopharmaceuticals believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan, Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One.

Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important targeted cancer treatments. The Company’s pipeline includes tovorafenib (OJEMDA™) and DAY301 and a VRK1 inhibitor program.

Day One is based in Brisbane, California. For more information, please visit www.dayonebio.com or find the Company on LinkedIn or X.

Day One uses its Investor Relations website (ir.dayonebio.com), its X handle (x.com/DayOneBio), and LinkedIn Home Page (linkedin.com/company/dayonebio) as a means of disseminating or providing notification of, among other things, news or announcements regarding its business or financial performance, investor events, press releases, and earnings releases, and as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Day One’s plans to develop and commercialize cancer therapies, expectations from current clinical trials, the execution of the Phase 2 and Phase 3 clinical trial for tovorafenib as designed, any expectations about safety, efficacy, timing and ability to complete clinical trials, release data results and to obtain regulatory approvals for tovorafenib and other candidates in development, and the ability of tovorafenib to treat pLGG or related indications.

Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.

Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Day One’s ability to develop, obtain and retain regulatory approval for or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of inflation, rising interest rates, instability in the global banking system, geopolitical conflicts and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

Day One Biopharmaceuticals, Inc.
Condensed Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
	Three Months Ended June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
Revenue:
Product revenue, net	$	8,192			$	—			$	8,192			$	—
Cost and operating expenses:
Cost of product revenue		707				—				707				—
Research and development		92,106				32,182				132,316				60,010
Selling, general and administrative		30,186				17,072				56,743				35,099
Total cost and operating expenses		122,999				49,254				189,766				95,109
Loss from operations		(114,807	)			(49,254	)			(181,574	)			(95,109	)
Non-operating income (expense)
Gain from sale of priority review voucher		108,000				—				108,000				—
Investment income, net		3,962				3,406				8,327				6,872
Other expense, net		(10	)			(15	)			(20	)			(19	)
Total non-operating income, net		111,952				3,391				116,307				6,853
Loss before income taxes		(2,855	)			(45,863	)			(65,267	)			(88,256	)
Income tax expense		(1,552	)			—				(1,552	)			—
Net loss	$	(4,407	)		$	(45,863	)		$	(66,819	)		$	(88,256	)
Net loss per share, basic and diluted	$	(0.05	)		$	(0.61	)		$	(0.77	)		$	(1.20	)
Weighted-average number of common shares used in computing net loss per share, basic and diluted		87,121,310				74,964,878				86,864,545				73,478,567

Day One Biopharmaceuticals, Inc.
Selected Condensed Balance Sheet Data
(in thousands)
(unaudited)
	June 30, 2024				December 31, 2023
Cash, cash equivalents and short-term investments	$	361,866			$	366,347
Total assets		400,437				376,048
Total liabilities		93,706				29,508
Accumulated deficit		(525,404	)			(458,585	)
Total stockholders’ equity	$	306,731			$	346,540

DAY ONE MEDIA
Laura Cooper, Head of Communications
media@dayonebio.com

DAY ONE INVESTORS
LifeSci Advisors, PJ Kelleher
pkelleher@lifesciadvisors.com

FAQ

What were Day One Biopharmaceuticals' (DAWN) Q2 2024 OJEMDATM revenues?

Day One Biopharmaceuticals (DAWN) reported $8.2 million in OJEMDATM (tovorafenib) net product revenues for Q2 2024, which represents the initial 2 months of launch.

What licensing agreement did Day One (DAWN) enter with Ipsen in July 2024?

Day One (DAWN) entered an exclusive licensing agreement with Ipsen to commercialize tovorafenib outside the U.S. for approximately $111 million upfront in cash and equity investment, with potential additional milestone payments of up to $350 million.

How much did Day One Biopharmaceuticals (DAWN) raise in their private placement in July 2024?

Day One Biopharmaceuticals (DAWN) entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175 million in July 2024.

What was Day One's (DAWN) cash position as of June 30, 2024?

Day One Biopharmaceuticals (DAWN) reported a cash position of $361.9 million, including cash, cash equivalents, and short-term investments, as of June 30, 2024.