SERA PROGNOSTICS REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS
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
Second Quarter 2024 Financial Results
Second quarter 2024 revenue was
Research and development expenses for the second quarter of 2024 were
Selling, general and administrative expenses for the second quarter of 2024 were
Lower costs resulted in a 21% narrower net loss for the second quarter of 2024 with a net loss of
Conference Call Information
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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
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
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,
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
Condensed Statements of Operations (unaudited) (in thousands, except share and per share data) |
|||||||
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|||||||
|
Three Months Ended
|
|
Six Months Ended
|
||||
|
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 |
Condensed Balance Sheets (unaudited) (in thousands) |
|||
|
|||
|
|
|
|
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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