SERA PROGNOSTICS REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS

Rhea-AI Summary

Sera Prognostics Inc. (Nasdaq: SERA) reported its Q2 2024 financial results. Key highlights include:

- Publication of positive AVERT PRETERM TRIAL results in Diagnostics journal
- Data analysis for PRIME study underway, with database lock expected mid-September
- Conditional approval from New York State for ambient whole-blood collection
- Implementation of cost-effective physician and patient education programs

Financial results:
- Q2 2024 revenue: $24,000 (down from $123,000 in Q2 2023)
- Total operating expenses: $9.3 million (20% decrease from Q2 2023)
- Net loss: $8.3 million (21% narrower than Q2 2023)

The company is focusing on expanding awareness of its PreTRM offering through multi-channel strategies and supporting the establishment of care guidelines based on test-and-treat data.

Positive

• Publication of positive AVERT PRETERM TRIAL results in a peer-reviewed journal
• Conditional approval from New York State for ambient whole-blood collection, enabling nationwide rollout
• 20% reduction in total operating expenses compared to Q2 2023
• 21% narrower net loss compared to Q2 2023
• Implementation of cost-effective education programs for physicians and patients

Negative

• Q2 2024 revenue decreased to $24,000 from $123,000 in Q2 2023
• Research and development expenses increased by 19% compared to Q2 2023
• Net loss of $8.3 million for Q2 2024

Financial Analyst

Sera Prognostics' Q2 2024 results show a concerning trend in revenue, with a $24,000 figure compared to $123,000 in Q2 2023, representing an 80.5% decline. This significant drop suggests challenges in commercialization of their PreTRM® Test.

On a positive note, the company has managed to reduce its operating expenses by 20% year-over-year, narrowing the net loss by 21% to $8.3 million. The cost-cutting measures, particularly in SG&A (down 38%), demonstrate management's efforts to extend the cash runway. However, the 19% increase in R&D expenses indicates continued investment in product development, which could be important for future growth.

The financial position remains precarious, with minimal revenue and substantial losses. Investors should closely monitor the company's cash burn rate and potential need for additional financing.

Medical Research Analyst

The publication of positive AVERT PRETERM TRIAL results in a peer-reviewed journal is a significant milestone for Sera Prognostics. This validation adds credibility to their PreTRM® Test and could potentially influence clinical adoption. The ongoing PRIME study, with database lock anticipated in mid-September, represents another crucial catalyst for the company.

The conditional approval from New York State for ambient whole-blood collection is a logistical improvement that could enhance test accessibility and potentially drive adoption. However, the stark revenue decline suggests that these scientific advancements have yet to translate into commercial success.

The company's focus on building an evidence portfolio through studies like AVERT and PRIME is a sound strategy in the medical field. If these studies consistently demonstrate clinical utility and cost-effectiveness, they could pave the way for inclusion in care guidelines, which is often a prerequisite for widespread adoption and reimbursement in the healthcare industry.

Market Research Analyst

Sera Prognostics' multi-channel marketing strategy, including engagement with medical professionals and direct-to-physician approaches, demonstrates a proactive effort to increase awareness of their PreTRM® Test. The high engagement reported on a leading platform for U.S. medical professionals is encouraging, but the revenue figures suggest these efforts have yet to yield significant commercial results.

The development of social media, email and broadcast TV strategies indicates a broader consumer-focused approach. This could be important in the pregnancy care market, where patient demand can drive adoption. However, the effectiveness of these strategies in a highly regulated medical field remains to be seen.

The company's focus on cost-effective programs aligns with their financial situation, but it may limit the reach and impact of their marketing efforts. The success of these initiatives will likely depend on the strength of the clinical data from studies like PRIME and their ability to translate scientific evidence into compelling value propositions for both healthcare providers and patients.

SALT LAKE CITY, Aug. 7, 2024 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced financial results for the second quarter of 2024 ended June 30, 2024.

Recent Highlights:

• Publication of positive AVERT PRETERM TRIAL (Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls) results in international peer-reviewed journal, Diagnostics, with coverage on front page of publication.
• Data analysis for final Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study begun and database lock anticipated mid-September with goal of publication in time for key pregnancy and maternal health conferences in the spring.
• Conditional approval received from New York State on ambient whole-blood collection, allowing Sera to complete nationwide rollout of new blood collection method.
• Executing variety of cost-effective programs to educate physicians and patients regarding benefits of Sera's PreTRM® Test, such as with a leading platform for U.S. medical professionals with results showing high engagement, a direct to physician multi-channel strategy, and development of social media, email, and broadcast TV strategies to broaden awareness.

"We are pleased to have achieved publication of our positive AVERT study results and look forward to the publication of our pivotal PRIME study, both of which we believe are necessary prerequisites for growing our evidence portfolio, adoption and building revenue over time," said Zhenya Lindgardt, President and CEO of Sera Prognostics. "To further expand awareness of the benefit of our PreTRM offering we are pursuing cost effective multi-channel strategies with focused investments where we anticipate the best impact for value delivered and, at the same time, working to support the establishment of care guidelines leveraging our compelling test-and-treat data."

Second Quarter 2024 Financial Results

Second quarter 2024 revenue was $24,000 compared to $123,000 for the same period of 2023. Total operating expenses were $9.3 million, down 20% from $11.5 million for the second quarter of 2023.

Research and development expenses for the second quarter of 2024 were $4.4 million, and up about 19% from $3.7 million for the second quarter of 2023 due primarily to new product development activities.

Selling, general and administrative expenses for the second quarter of 2024 were $4.9 million, down 38% from $7.8 million for the second quarter of 2023 due primarily to steps to streamline commercial operations, better focus our commercial strategy and reduce overall operating expenses.

Lower costs resulted in a 21% narrower net loss for the second quarter of 2024 with a net loss of $8.3 million compared to $10.5 million for the same quarter a year ago.

Conference Call Information

Sera Prognostics will host a corresponding conference call and live webcast today to discuss second quarter 2024 operational highlights, financial results and key topics at 5:00 p.m. Eastern Time. Individuals interested in listening to the conference call may do so by dialing the following:

US domestic callers: (800) 836-8184

International callers: (646) 357-8785

Webcast Registration Link: https://app.webinar.net/9o5EWBrWj02

Live audio of the webcast will be available online from the Investors page of the Company's website at www.seraprognostics.com. The webcast will be archived on the Investors page and will be available for one year.

About Sera Prognostics, Inc.

Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera's mission is to provide early, pivotal pregnancy information to improve the health of mothers and newborns, resulting in reductions in the costs of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera's precision medicine PreTRM® Test reports to a physician the individualized risk of spontaneous premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is headquartered in Salt Lake City, Utah.

About Preterm Birth

Preterm birth is defined as any birth before 37 weeks' gestation and is the leading cause of illness and death in newborns. The 2023 March of Dimes Report Card shows that, for the last five consecutive years, more than one in ten infants is born prematurely in the United States. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual health care costs to manage short- and long-term complications of prematurity in the United States were estimated to be approximately $25 billion for 2016.

About the PreTRM® Test

The PreTRM® Test is the only broadly validated, commercially available blood-based biomarker test that provides an early, accurate and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies. The PreTRM® Test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM® Test permits physicians to identify, during the weeks 18 through 20 of pregnancy, which women are at increased risk for preterm birth and its complications, enabling more informed, personalized clinical decisions based on each woman's individual risk. The PreTRM® Test is ordered by a medical professional.

Sera, Sera Prognostics, the Sera Prognostics logo, The Pregnancy Company, and PreTRM are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States and/or other countries.

Safe Harbor Statement

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to final PRIME database lock in mid-September; PRIME publication in time for key pregnancy and maternal health conferences in the spring; cost-effective programs to educate patients and physicians on the PreTRM® Test, such as a leading platform for U.S. medical professionals with results showing high engagement, a direct to physician multi-channel strategy, and development of social media, email, and broadcast TV strategies to broaden awareness; establishment of care guidelines; and the company's strategic directives under the caption "About Sera Prognostics, Inc." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: net losses, cash generation, and the potential need to raise more capital; revenues from the PreTRM Test representing substantially all Company revenues to date; the need for broad scientific and market acceptance of the PreTRM Test; a concentrated number of material customers; our ability to introduce new products; potential competition; our proprietary biobank; critical suppliers; the COVID-19 pandemic and its potential lingering impact on our operations, as well as the business or operations of third parties with whom we conduct business; estimates of total addressable market opportunity and forecasts of market growth; potential third-party payer coverage and reimbursement; new reimbursement methodologies applicable to the PreTRM Test, including new CPT codes and payment rates for those codes; changes in FDA regulation of laboratory-developed tests; the intellectual property rights protecting our tests and market position; and other factors discussed under the heading "Risk Factors" contained in our Final Prospectus on Form S-1, which was filed with the Securities and Exchange Commission on July 14, 2021, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

SERA PROGNOSTICS, INC. Condensed Statements of Operations (unaudited) (in thousands, except share and per share data)
	Three Months Ended June 30,				Six Months Ended June 30,
	2024		2023		2024		2023
Revenue	$                   24		$                 123		$                   24		$                 223
Operating expenses:
Cost of revenue	20		80		37		142
Research and development	4,406		3,688		8,089		7,791
Selling and marketing	1,099		2,872		2,326		5,690
General and administrative	3,752		4,943		7,922		9,389
Total operating expenses	9,277		11,583		18,374		23,012
Loss from operations	(9,253)		(11,460)		(18,350)		(22,789)
Interest expense	(8)		(14)		(17)		(30)
Other income, net	958		932		1,967		1,712
Net loss	$            (8,303)		$          (10,542)		$          (16,400)		$          (21,107)
Net loss per share, basic and diluted	$              (0.25)		$              (0.34)		$              (0.50)		$              (0.68)
Weighted-average shares outstanding, basic and diluted	32,932,903		31,077,420		32,576,470		31,048,526

 

SERA PROGNOSTICS, INC. Condensed Balance Sheets (unaudited) (in thousands)
	June 30, 2024		December 31, 2023
Assets
Current assets:
Cash and cash equivalents	$               4,664		$               3,880
Marketable securities	46,276		45,199
Accounts receivable	101		160
Other receivables	—		11,310
Prepaid expenses and other current assets	502		795
Total current assets	51,543		61,344
Property and equipment, net	1,607		1,999
Long-term marketable securities	30,006		30,841
Other assets	1,705		1,257
Total assets	$             84,861		$             95,441
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$                  952		$               1,046
Accrued and other current liabilities	3,181		2,722
Finance lease obligation, current portion	396		440
Deferred revenue	20,228		20,235
Total current liabilities	24,757		24,443
Finance lease obligation, net of current portion	23		196
Operating lease obligation, net of current portion	328		644
Total liabilities	25,108		25,283
Commitments and contingencies
Stockholders' equity:
Common stock, Class A and Class B	3		3
Additional paid-in capital	323,257		317,066
Accumulated other comprehensive loss	(211)		(15)
Accumulated deficit	(263,296)		(246,896)
Total stockholders' equity	59,753		70,158
Total liabilities and stockholders' equity	$             84,861		$             95,441

 

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SOURCE Sera Prognostics, Inc.

FAQ

What were Sera Prognostics' (SERA) Q2 2024 financial results?

Sera Prognostics reported Q2 2024 revenue of $24,000, total operating expenses of $9.3 million, and a net loss of $8.3 million.

How did Sera Prognostics' (SERA) Q2 2024 results compare to Q2 2023?

Compared to Q2 2023, Sera Prognostics' revenue decreased, total operating expenses reduced by 20%, and the net loss narrowed by 21%.

What major clinical trial results did Sera Prognostics (SERA) report in Q2 2024?

Sera Prognostics reported the publication of positive AVERT PRETERM TRIAL results in the international peer-reviewed journal, Diagnostics.

What regulatory approval did Sera Prognostics (SERA) receive in Q2 2024?

Sera Prognostics received conditional approval from New York State for ambient whole-blood collection, allowing for a nationwide rollout of their new blood collection method.