Full Press Release Details
SERA PROGNOSTICS REPORTS SECOND QUARTER 2021
Lake City - August 30, 2021 - 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 ended June 30, 2021.
are pleased with the progress we made during the quarter, as we build momentum to achieve our vision of improving maternal and neonatal
health through our proprietary proteomic testing platform," stated Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera Prognostics.
"Our innovative PreTRM test is the only broadly validated commercially available blood-based biomarker test, that has
been proven to identify moms and babies at higher risk for spontaneous preterm birth, thereby enabling health and economic benefits by
intervening proactively in such pregnancies. We look forward to further announcements illustrating the benefits of the PreTRM Test
and Treat strategy, in the form of additional publications of studies and development of new commercial payer contracts."
Second Quarter 2021 Financial Results
Second quarter 2021 revenue of $20,000 compared
to $6,000 for the same period of 2020.
Total operating expenses were $7.4 million, up
from $4.3 million for the second quarter of 2020.
Research and development expenses for the second
quarter of 2021 were $2.8 million compared to $1.8 million for the prior-year period due primarily to increased laboratory operations
and clinical study costs.
Selling, general and administrative expenses for
the second quarter of 2021 were $4.6 million, up from $2.5 million due primarily to increased headcount as the company scaled commercial
operations and general corporate infrastructure, as well as increased consulting and outside services related to payer and reimbursement
Net loss for the second quarter of 2021 was $6.3
million compared to $4.7 million for the same quarter a year ago.
As of June 30, 2021, cash and cash equivalents
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 deliver early,
pivotal information in pregnancy to physicians, enabling them to improve the health of their patients, 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 located in Salt Lake City, Utah.
Preterm birth is defined as any birth before 37
weeks' gestation and is the leading cause of illness and death in newborns. The 2020 March of Dimes Report Card shows that
of approximately 3.8 million babies born annually in the United States, more than one in ten is born prematurely. 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
have been estimated to be approximately $25 billion.
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 19th or 20th week of pregnancy, which women are at increased risk for preterm birth, enabling more informed, personalized clinical
decisions based on each woman's individual risk. The PreTRM test is ordered by a medical professional.
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
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 the results
of the HealthCore study potentially being published in a peer-reviewed clinical economics research journal; further announcements illustrating
the benefits of the PreTRM Test and Treat strategy, in the form of additional publications of studies and development of new commercial
payer contracts; 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 ongoing COVID-19 pandemic and its 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.
Peter DeNardo, CapComm Partners
SERA PROGNOSTICS, INC.
Condensed Statements of Operations and Comprehensive Loss
thousands, except share and per share data)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | $ | 20 | $ | 6 | $ | 33 | $ | 14 | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue | 8 | 2 | 13 | 6 | ||||||||||||
| Research and development | 2,824 | 1,752 | 5,221 | 3,801 | ||||||||||||
| Selling and marketing | 1,740 | 712 | 3,090 | 1,580 | ||||||||||||
| General and administrative | 2,829 | 1,821 | 5,116 | 3,200 | ||||||||||||
| Total operating expenses | 7,401 | 4,287 | 13,440 | 8,587 | ||||||||||||
| Loss from operations | (7,381 | ) | (4,281 | ) | (13,407 | ) | (8,573 | ) | ||||||||
| Interest expense | 2 | (420 | ) | (305 | ) | (857 | ) | |||||||||
| Other income (expense), net | 1,072 | (4 | ) | 1,046 | 29 | |||||||||||
| Net loss and comprehensive loss | $ | (6,307 | ) | $ | (4,705 | ) | $ | (12,666 | ) | $ | (9,401 | ) | ||||
| Net loss per share, basic and diluted | $ | (3.17 | ) | $ | (3.08 | ) | $ | (6.70 | ) | $ | (6.16 | ) | ||||
| Weighted-average shares of common stock outstanding, basic and diluted | 1,988,886 | 1,525,648 | 1,890,908 | 1,525,491 |
SERA PROGNOSTICS, INC.
Condensed Balance Sheets
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 90,851 | $ | 13,533 | ||||
| Accounts receivable | 14 | 2 | ||||||
| Prepaid expenses and other current assets | 503 | 198 | ||||||
| Total current assets | 91,368 | 13,733 | ||||||
| Property and equipment, net | 871 | 965 | ||||||
| Other assets | 2,828 | 98 | ||||||
| Total assets | $ | 95,067 | $ | 14,796 | ||||
| Liabilities, Convertible Preferred Stock, and Stockholders' Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,026 | $ | 441 | ||||
| Accrued and other current liabilities | 1,997 | 1,577 | ||||||
| Accrued interest on convertible note | - | 996 | ||||||
| Deferred rent, current portion | 138 | 130 | ||||||
| Capital lease obligation, current portion | 71 | 69 | ||||||
| Convertible promissory note, current portion | - | 4,353 | ||||||
| Loans payable, current portion | - | 3,676 | ||||||
| Total current liabilities | 3,232 | 11,242 | ||||||
| Deferred rent | 69 | 139 | ||||||
| Loans payable, net of current portion | - | 348 | ||||||
| Preferred stock warrant liability | 485 | 474 | ||||||
| Capital lease obligation, net of current portion | 91 | 127 | ||||||
| Total liabilities | 3,877 | 12,330 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred stock: | ||||||||
| Junior convertible preferred stock | 77,844 | 77,844 | ||||||
| Senior convertible preferred stock | 149,144 | 50,192 | ||||||
| Stockholders' deficit: | ||||||||
| Class A common stock | - | - | ||||||
| Class B common stock | - | - | ||||||
| Additional paid-in capital | 8,327 | 5,889 | ||||||
| Accumulated deficit | (144,125 | ) | (131,459 | ) | ||||
| Total stockholders' deficit | (135,798 | ) | (125,570 | ) | ||||
| Total liabilities, convertible preferred stock, and stockholders' deficit | $ | 95,067 | $ | 14,796 |