Market Newsdesk

– REZZAYO is a novel, once-weekly, next-generation echinocandin indicated for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options –

– REZZAYO is the first new FDA-approved echinocandin in over a decade –

SAN DIEGO and PARSIPPANY, N.J., March 22, 2023 (GLOBE NEWSWIRE) — Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration (FDA) approved REZZAYO™ (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade.

“The FDA approval of REZZAYO represents a significant milestone for Cidara, and for patients confronted with difficult-to-treat and often deadly candidemia and invasive candidiasis,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “I am extremely proud of all of the Cidara employees who collectively advanced REZZAYO from preclinical development to NDA approval and am grateful to the many patients and healthcare teams who have participated in the clinical studies.”

George Thompson, M.D., principal investigator in the ReSTORE trial and professor of clinical medicine at the University of California, Davis, School of Medicine, added, “The FDA approval of REZZAYO is tremendous news for those of us who have been hoping for a new option to treat our patients with these deadly fungal infections. Based on the totality of clinical data generated, REZZAYO has the potential to simplify the management of invasive candidiasis and enhance the continuity of echinocandin care.”

The FDA approval of once-weekly REZZAYO was based on clinical data from Cidara’s global ReSTORE Phase 3 trial and supported by the STRIVE Phase 2 clinical trial and extensive non-clinical development program. In clinical studies, REZZAYO, dosed once-weekly, met the FDA and EMA primary endpoints, demonstrating statistical non-inferiority versus caspofungin, a current once-daily standard of care. In addition, overall rates of adverse events and serious adverse events were comparable in patients receiving REZZAYO and caspofungin, while rates of adverse events leading to study drug discontinuation were also similar for REZZAYO and caspofungin. Based on Qualified Infectious Disease Product (QIDP) designation, REZZAYO was approved under Priority Review.

Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, added, “We are thrilled that the FDA has approved REZZAYO, and are firmly committed to offering this innovative therapy to address unmet medical needs and simplify the treatment for patients suffering from invasive Candida infections. We intend to leverage our expansive commercial infrastructure and experience launching anti-infective drugs into acute care settings. We are working closely with Cidara and anticipate bringing REZZAYO, a differentiated once-weekly treatment to patients, this summer.”

Last year, Melinta announced that it had acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara. Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma in all other geographies. The European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for rezafungin in August 2022 and it is currently under review.

About REZZAYO™
 (rezafungin for injection)

REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.

INDICATIONS AND USE

REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.

REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

IMPORTANT SAFETY INFORMATION

REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.

REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.

Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.

Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.

About Cidara Therapeutics

Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms leveraging drug-Fc conjugates (DFCs) targeting viral and oncological diseases from Cidara’s proprietary Cloudbreak^® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

About Melinta Therapeutics

Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our commercial portfolio currently includes the newly approved REZZAYO (rezafungin for injection), in addition to six commercial-stage products: Baxdela^® (delafloxacin), Kimyrsa^® (oritavancin), Minocin^® (minocycline) for Injection, Orbactiv^® (oritavancin), TOPROL-XL^® (metoprolol succinate) and Vabomere^® (meropenem and vaborbactam).

With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. For additional information, including product and respective important safety information, please visit our website.

TOPROL-XL^® is a registered trademark of the AstraZeneca group of companies.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether REZZAYO will be commercially available for patients during summer 2023, whether REZZAYO, if available, will be prescribed by physicians or will represent an important treatment option for patients with serious fungal infections. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of rezafungin development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

Investor Contact:

Brian Ritchie
LifeSci Advisors
(212) 915-2578
[email protected]

Media Contact:

Veronica Eames
LifeSci Communications
646-970-4682
[email protected]

Melinta Contact:

Susan Blum
908-617-1300
[email protected]

– SENTI-202 on track to submit an Investigational New Drug (IND) application in second half of 2023 for treatment of CD33 and/or FLT3 expressing hematologic malignancies including AML and MDS –

– Preclinical data from multiple Gene Circuit enhanced CAR NK programs to be presented at American Association for Cancer Research (AACR) Annual Meeting in April 2023 –

– Cash, cash equivalents, and short-term investments of $98.6 million as of December 31, 2022; continue to expect cash runway through at least 1Q 2024 –

SOUTH SAN FRANCISCO, Calif., March 22, 2023 (GLOBE NEWSWIRE) — Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a biotechnology company innovating next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the fourth quarter and full year ended December 31, 2022.

“2022 was a year of important progress for Senti in developing Gene Circuit enhanced next-generation cell therapies that are designed to precisely target cancer cells and overcome the complex tumor environment in oncology. We advanced our product candidates towards clinical development by selecting the lead development candidate in our SENTI-202 program, and expanded our manufacturing capabilities with the ongoing build out of our cGMP facility,” said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio. “Importantly, in 2022 we became a public company and are well positioned in 2023 to continue to be at the forefront of the synthetic biology field as we prepare to submit our first IND application for SENTI-202, continue to advance our pipeline programs, and establish robust clinical-scale manufacturing of CAR NK cells. Furthermore, our ongoing collaboration efforts to develop next-generation cell and gene therapies in areas outside of oncology with Spark Therapeutics and BlueRock Therapeutics underscore our continued leadership position in Gene Circuits.”

Recent CAR-NK Cell Oncology Pipeline and Gene Circuit Platform Highlights:

• Announced strategic plan to focus research and development efforts on lead oncology candidate SENTI-202 for the treatment CD33 and/or FLT3 expressing hematologic malignancies including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), to continue to advance SENTI-401 through preclinical studies to target colorectal cancer and other CEA-positive solid tumors, and to pursue strategic geographic partnerships for clinical development of SENTI-301A for liver cancer, of which there is high prevalence in Asian territories.
• Presented SENTI-202 preclinical data at the American Society of Hematology (ASH) meeting in December 2022 highlighting the use of Logic Gating Gene Circuits to target and eliminate AML cells while sparing healthy hematopoietic stem cells (HSCs). The in vitro and in vivo data demonstrated the ability of SENTI-202 to broadly kill primary leukemic blasts and leukemic stem cells, as well as relevant AML cell lines, while concurrently protecting healthy human HSCs.
• Initiated IND-enabling studies for SENTI-202 to support a planned Phase 1 trial with submission of an IND application to the FDA anticipated in the second half of 2023.
• Initiated process and analytical technology transfer to Senti Bio’s Alameda current good manufacturing practice (cGMP) facility to support clinical-scale manufacturing for the company’s CAR NK cell development candidates.
• Announced presentation of three abstracts highlighting preclinical data from the company’s Gene Circuit CAR NK cell oncology pipeline including SENTI-202, the calibrated release IL-15 Gene Circuit technology, and SENTI-301A, at the AACR Annual Meeting taking place April 14-19, 2023, in Orlando, Florida.
• Presented preclinical proof-of-concept data from the SENTI-401 CAR NK cell therapy development program at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2022 that showed robust anti-cancer functionality of Logic Gated, Multi-Armed CAR NK cells against a variety of colorectal cancer (CRC) models, including durable activity in vivo; Senti Bio is continuing to advance the SENTI-401 program through preclinical studies intended to support development candidate selection.
• Achieved discovery-stage objectives supporting continued advancement of next-generation Smart Sensor cell-type and cell-state specific promoters for various non-oncology indications in collaboration with Spark Therapeutics, and advanced a Regulator Dial Gene Circuit designed to enable small molecule-controlled release of cytokines/ “safety switches” in collaboration with BlueRock Therapeutics.

Fourth Quarter and Full Year 2022 Financial Results

• Cash, Cash Equivalents and Short-term Investments: As of December 31, 2022, Senti Bio held cash, cash equivalents and short-term investments of $98.6 million, which the Company believes is sufficient to fund operations through at least the first quarter of 2024.
• R&D Expenses: Research & development expenses were $9.2 million for the quarter ended December 31, 2022, compared to $6.4 million for the same period in 2021. Research and development expenses for the year ended December 31, 2022 were $34.1 million, compared to $22.0 million in 2021. The increase includes an additional $2.7 million in non-cash stock-based compensation expense.
• G&A Expenses: General and administrative expenses were $10.9 million for the fourth quarter of 2022, compared to $5.3 million for the same period in 2021. General and administrative expenses for the year ended December 31, 2022 were $40.8 million, compared to $21.3 million in 2021. The increase includes an additional $11.4 million in non-cash stock-based compensation expense.
• Net Loss: Net loss was $18.2 million, or $0.42 per basic and diluted share, for the quarter ended December 31, 2022. Net loss for the year ended December 31, 2022, was $58.2 million, or $2.23 per share, compared to a net loss of $55.3 million, or $19.00 per share, in 2021.
• CapEx: Capital expenditures were $8.5 million for the quarter ended December 31, 2022, primarily driven by the GMP manufacturing facility buildout and related equipment purchases.

About Senti Bio

Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches. To accomplish this, we are building a synthetic biology platform that may enable us to program next-generation cell and gene therapies with what we refer to as Gene Circuits. These novel and proprietary Gene Circuits are designed to reprogram cells with biological logic to sense inputs, compute decisions and respond to their cellular environments. We aim to design Gene Circuits to improve the intelligence of cell and gene therapies in order to enhance their therapeutic effectiveness, precision, and durability against a broad range of diseases that conventional medicines do not readily address.

Our synthetic biology platform utilizes off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cells, outfitted with Gene Circuit technologies, to target particularly challenging liquid and solid tumor oncology indications. Our lead product candidate is SENTI-202 for the treatment of CD33 and/or FLT3 expressing hematologic malignancies, such as acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Additionally, our SENTI-401 program is being designed for the treatment of colorectal cancer (CRC) and other CEA-positive cancers. We have also demonstrated in preclinical studies the potential breadth of our Gene Circuits in other modalities, including T cells, adeno-associated viruses (AAVs) and induced pluripotent stem cells (iPSCs), and diseases outside of oncology; and we have executed partnerships with Spark Therapeutics and BlueRock Therapeutics to advance these capabilities.

Forward-Looking Statements

This press release and document contain certain statements that are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally are identified by the words “believe,” “could,” “predict,” “continue,” “ongoing,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” “forecast,” “seek,” “target” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations of Senti Bio’s management and assumptions, whether or not identified in this document, and, as a result, are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of financial and cash runway and the sufficiency of such cash runway, Senti Bio’s ability to continue to advance its pipeline of preclinical programs and product candidates, Senti Bio’s research and development activities, the generation and release of additional preclinical data, commencement of IND-enabling studies and the timing of submission of IND filings, plans for a Phase 1 clinical trial, and GMP manufacturing start up activities, as well as statements about the potential attributes and benefits of Senti Bio’s product candidates and platform technology and the continuation of its collaborations with Spark Therapeutics and BlueRock Therapeutics. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Senti Bio. Many factors could cause actual future results to differ materially from the forward-looking statements in this document, including but not limited to: (i) Senti Bio’s ability to implement business plans, forecasts and other expectations, (ii) changes in domestic and foreign business, market, financial, political and legal conditions, (iii) changes in the competitive and highly regulated industries in which Senti Bio operates, variations in operating performance across competitors, changes in laws and regulations affecting Senti Bio’s business, (iv) the ability to implement business plans, forecasts and other expectations, (v) the risk of downturns and a changing regulatory landscape in Senti Bio’s highly competitive industry, (vi) risks relating to the uncertainty of any projected financial information with respect to Senti Bio, (vii) risks related to uncertainty in the timing or results of Senti Bio’s preclinical studies, IND filings, and GMP manufacturing startup activities, (viii) Senti Bio’s dependence on third parties in connection with preclinical and IND-enabling studies, IND filings, and GMP manufacturing buildout and startup activities, (ix) risks related to delays and other impacts from macroeconomic and geopolitical events, including changing conditions from the COVID-19 pandemic, increasing rates of inflation and rising interest rates on business operations, and (x) the success of any future research and development efforts by Senti Bio. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Senti Bio’s Quarterly Report on Form 10-Q, filed with the SEC on November 10, 2022, and other documents filed by Senti Bio from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements in this document. There may be additional risks that Senti Bio does not presently know, or that Senti Bio currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements in this document. Forward-looking statements speak only as of the date they are made. Senti Bio anticipates that subsequent events and developments may cause Senti Bio’s assessments to change. Except as required by law, Senti Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.

Availability of Other Information About Senti Biosciences, Inc.

For more information, please visit the Senti Bio website at https://www.sentibio.com or follow Senti Bio on Linkedin (Senti Biosciences). Investors and others should note that we communicate with our investors and the public using our company website (www.sentibio.com), including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on social media. The information that we post on our website or on social media could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Find more information at sentibio.com
Follow us on Linkedin: Senti Biosciences

Senti Biosciences, Inc.

Unaudited Selected Consolidated Balance Sheet Data

(in thousands)

Senti Biosciences, Inc.

Unaudited Consolidated Statements of Operations

(in thousands, except share and per share data)

Company prioritizing pipeline to focus on CTIM-76 development and discontinuing ONA-XR program

Cash runway extended into late 2024

CTIM-76 preclinical data to be presented at AACR Annual Meeting 2023

PHILADELPHIA, March 22, 2023 (GLOBE NEWSWIRE) — Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company developing novel treatments for solid tumors, today announced financial results for the year ended December 31, 2022. Additionally, the Company announced a portfolio prioritization and capital allocation strategy that is expected to extend its cash runway into late 2024. The resulting changes include discontinuing the development of onapristone extended release (ONA-XR) and focusing on the development of CTIM-76, its Claudin 6 (CLDN6) bispecific antibody clinical candidate.

“Given the challenging market conditions for emerging companies, the increasingly competitive landscape for breast cancer treatments, and recent study findings, we have decided to discontinue the development of ONA-XR,” said Martin Lehr, CEO of Context. “We are shifting our development focus to our compelling preclinical asset CTIM-76, a CLDN6 x CD3 bispecific antibody. Additionally, we’re pleased that preclinical data regarding CTIM-76 will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023 in April and look forward to hosting an investor R&D webinar on the data following that presentation.”

Context ended the fourth quarter of 2022 with approximately $35.5 million in cash and cash equivalents. Based on its pipeline prioritization and related expense reduction, the Company expects to have sufficient financial resources to fund CTIM-76 beyond the filing of its Investigational New Drug (IND) Application, which is expected to occur in Q1 2024. The Company does not anticipate any headcount reductions related to its portfolio prioritization.

CTIM-76 Program Overview

There is a large unmet need for targeted therapies to treat solid tumors. CTIM-76 is a CLDN6 x CD3 bispecific antibody that simultaneously binds to CLDN6 expressing cancer cells and CD3 expressing immune T cells. In this manner, CTIM-76 functions as an immunotherapy that recruits a patient’s own immune system to attack cancer cells. CLDN6 is a developmental gene that is required for cell growth and that is silenced after birth. Some cancers, including ovarian, lung, and testicular, reactivate this developmental gene to promote cancer cell growth and survival. Therefore, therapeutic inhibition of CLDN6 via CTIM-76 immunotherapy may restrict the growth of CLDN6-positive cancer cells. Preclinical studies suggest the potential for convenient dosing and scalable manufacturing to address the significant number of patients who have CLDN6-positive disease.

ONA-XR Recent Study Findings

In the ongoing Phase 2 OATH trial evaluating ONA-XR in combination with anastrozole, elevated liver function tests (LFT) were identified in three patients, including in one patient who discontinued treatment, although none of the elevated LFTs were considered serious adverse events. The Company determined that significant incremental program costs and delays were likely to be required to analyze and potentially mitigate future LFT abnormalities. Based upon the challenging market conditions for emerging companies, the increasingly competitive landscape for breast cancer treatments, recent study findings, and other factors, the Company decided to cease development and explore strategic options for ONA-XR. As a result, the Company will no longer primarily focus on female cancers.

Strategy and Recent Pipeline Updates

• In March 2023, announced research regarding CTIM-76 will be presented on Monday, April 17 at 9 a.m. ET at the AACR Annual Meeting 2023, taking place April 14-19 in Orlando, FL. Details about the presentations can be found here. Additionally on April 17 at 4:30 p.m. ET, Context will host an investor R&D webinar with the Company’s management team and AACR presenter to discuss the presentation. To register for this event, please click here.
• In January 2023, announced a collaboration with Lonza, a global development and manufacturing partner to the pharma, biotech, and nutrition industries, to manufacture CTIM-76, Context’s clinical development candidate. CTIM-76 is a CLDN6 x CD3 T-cell engaging bispecific antibody targeting CLDN6-positive tumors.
• In November 2022, announced the selection of CTIM-76 as the Company’s lead clinical development candidate to target CLDN6-positive cancers, resulting from Context’s research collaboration and licensing agreement with Integral Molecular. IND-enabling studies have been initiated and Context expects to submit an IND Application to support human clinical trials for CTIM-76 in Q1 2024.

Full Year 2022 Financial Results

• Cash, cash equivalents, and restricted cash were $35.5 million at December 31, 2022, compared to $49.7 million at December 31, 2021.
• Acquired in-process research and development expense was $0.5 million for 2022, as compared to $3.1 million for the same period in 2021. The 2022 expense was due to a development milestone achieved under our collaboration and license agreement with Integral Molecular for the development of CTIM-76, while the 2021 expense reflects the fair value of consideration paid/equity issued under that same agreement.
• Research and development (R&D) expenses were $7.1 million for 2022, as compared to $3.8 million for the same period in 2021. The increase in R&D expenses was primarily driven by higher contract manufacturing costs and clinical trial costs related to our ONA-XR program and increased preclinical costs for CTIM-76.
• General and administrative (G&A) expenses were $7.8 million for 2022, as compared to $3.6 million for the same period in 2021. The increase in G&A expenses was primarily due to higher employee compensation expense as a result of an increase in headcount and changes to compensation arrangements, as well as higher insurance and professional fees to support ongoing business operations and compliance obligations associated with being a publicly traded company.
• Context reported a net loss of $14.8 million for 2022, as compared to $10.5 million for the same period in 2021.

2023 Cash Guidance

The Company expects its cash and cash equivalents will be sufficient to fund its operations into late 2024.

About Context Therapeutics
^®

Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company committed to advancing medicines for solid tumors. Context is developing CTIM-76, a selective Claudin 6 (CLDN6) x CD3 bispecific antibody for CLDN6-positive tumors, currently in preclinical development. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on Twitter and LinkedIn.

Forward-looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the ability of the Company, its employees and certain AACR presenters to participate in and present at conferences and webinars, (ii) the expectation to have an IND submission for CTIM-76 in the first quarter of 2024, (iii) having sufficient cash to fund our current operations into late 2024, (iv) the intention to cease development and explore strategic options for ONA-XR, (v) the intention to no longer primarily focus on female cancers, (vi) the expectation that there will be no headcount reductions related to our portfolio prioritization, (vii) the timing, enrollment and results of our clinical trials, (viii) the potential benefits and side effect profile of our product candidates, (ix) the likelihood data will support future development, and (x) the likelihood of obtaining regulatory approval of our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Media Contact:

Gina Cestari
6 Degrees
917-797-7904
[email protected]

Investor Relations Contact:

Laine Yonker
Edison Group
[email protected]

ERYTECH Provides
Business
and Financial
Update

for the
Fourth
Quarter
and Full Year
20
2
2

        

• Combination with
  Pherecydes
  a
  nnounced
  , i
  ntending to
  c
  reate
  a g
  lobal
  l
  eader in
  e
  xtended
  p
  hage
  t
  herapies
  t
  argeting
  antimicrobial resistant p
  athogenic
  b
  acteria

• Deep restructuring implemented; team size reduced by approximately 75% since start of
  2022
• Cash and cash equivalents of €
  38.8
  million ($
  41.5
  million) at the end of
  December
  2022

Cambridge, MA (U.S.)
and Lyon (France)
,
March 22
, 202
3
–
ERYTECH Pharma
(Nasdaq & Euronext: ERYP),
a
clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today
provided a business
and financial
update
for the
fourth
quarter
and full year
of
2022
.

“After
the disappointing results of our
Phase 3 trial in pancreatic cancer
, we have
pursued
during 2022
a consistent strategy to maximize the remaining value for our shareholders through strategic partnering. We sold our US manufacturing site, sharply reduced our cash
burn
, focus
ed on
our most promising preclinical programs
,
and relentlessly pursued part
n
ering options
”
,
said Gil Beyen, C
hief
E
xecutive
O
fficer
of ERYTECH.

“

We are very pleased this resulted in the
recently
announced s
trategic combination
with Pherecydes
to build on complementary expertise and capabilities of both companies
and
c
reate
a g
lobal
l
eader in
phage therapy to address the
increasingly alarming health context caused by antimicrobial-resistant bacteria
.
”

Business Highlights

• U.S. cell therapy manufacturing facility sold to Catalent for a total consideration of USD 44.5 million

Following the disappointing results of the Company’s Phase 3 trial in pancreatic cancer, ERYTECH in April 2022 sold its state-of-the-art commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, to Catalent for a total consideration of $44.5 million. ERYTECH’s staff at the site of approximately 40 people has been transferred to Catalent.

• Graspa
  ®
  program halted
  and focused shifted to preclinical RBC vesicles program

After FDA feedback on the envisaged BLA submission for Graspa® in hypersensitive ALL setback, and a non-conclusive early readout of first patients in a Phase 2 trial in TNBC, with the same product candidate, ERYTECH decided in September 2022 to halt further development of Graspa®, L-asparaginase encapsulated in donor red blood cells. Erytech decided to focus its development efforts on its most promising preclinical programs, the vesiculation of red blood cells that have already been loaded with active therapeutics to produce cargo-loaded RBC-derived extracellular vesicles, for the development of novel therapeutic approaches.

• Deep restructuring implemented

Linked to the halt of the Company’s lead program Graspa®, a restructuring program was initiated in May 2022. Combined with the approximately 40 people who transferred to Catalent after the sale of the Company’s manufacturing facility in Princeton, the global team size will be less than 25% compared to the start of this year. The Company has retained its R&D team and its expertise in key functional areas to keep the ability to restart a pipeline of partnered development programs and maintain a fully operational dual-listed company.

• Combination with Pherecydes announced

On February 15, 2023, the Company announced the strategic combination with Pherecydes, a biotechnology company specializing in precision phage therapy to treat resistant and/or complicated bacterial infections, with the ambition to create a global leader in extended phage therapy and accelerate the development of a portfolio of phage candidates targeting pathogenic bacteria.

The proposed transaction seeks to leverage ERYTECH’s financial resources and teams to both accelerate and expand PHERECYDES’ existing phage development programs and reinforce efforts to advance novel phage candidates.

ERYTECH and PHERECYDES intend to merge their operations and relocate all teams to ERYTECH’s premises in Lyon, where they will benefit from presence in a major European hub for infectious diseases.

The combined company’s cash runway would extend into Q3 2024, with a consolidated cash position of approximately €41 million as of December 31, 2022, and would enable funding of existing and novel programs through multiple clinical milestones.

The proposed transaction is structured as a merger of PHERECYDES into ERYTECH, pursuant to which the shareholders of PHERECYDES would receive newly issued ERYTECH ordinary shares in consideration of the contribution of the assets and liabilities of PHERECYDES. The extraordinary general meetings of ERYTECH and PHERECYDES will be called upon to vote on the proposed merger, currently expected to be convened at the end of June of 2023. The proposed transaction is expected to close shortly after the approval by the EGM.

Full Year
202
2
Financial Results

• Key financial figures for the twelve months of 2022 compared with the same period of the previous year are summarized below:

• Net loss for the full year of 2022 was €0.2 million, a €53.7 million improvement year-over-year, reflecting the €24.4 million net gain on the sale of the Princeton facility, and the further decrease in operating expenses, which, at €33.8 million of expenses at the end of 2022, were also showing an accelerated decrease of €26.9 million (-44%) year-over-year, with a €25.2 million decrease in R&D expenses (-56%), related to the termination of clinical programs, and a €1.7 million decrease (-11%) in G&A.
• Other income included the €4.9 million debt extinguishment related to the conditional advance on the Tedac R&D program, owing to the termination of developments on the Graspa® platform, and €1.5M for the R&D tax credit.

• Total operating expenses of €33.8 million included an impairment charge of €2.4 million on the Lyon production facility, related to the end of eryaspase operations, and a one-off €1.8 million cost of restructuring, related to the resizing of French operations and staff.
• Income tax expense in 2022 was €0.5 million, reflecting the expected tax impacts of the capital gain from the sale of the Princeton facility.
• As of December 31, 2022, ERYTECH had cash and cash equivalents totaling €38.8 million (approximately $41.5 million), compared with €33.7 million as of December 31, 2021. The €5.1 million net increase in cash position during the twelve months of 2022 was the result of the net cash of €37.6 million received from the sale of the Princeton facility, a €31.3 million net cash utilization in operating activities and investing activities (excluding the sale of the Princeton facility) and €1.8 million used in financing activities, while the variation of the U.S. dollar against the euro led to a €0.5 million positive currency exchange impact.
• Earlier this year, the company initiated a deep restructuring and cost reduction program, then further intensified with the halt of the Graspa® program and BLA process. Considering this ongoing reduction in operating expenses, the Company believes that its current cash position can fund its current activities and planned operating expenses to the second half of 2024.

F
iling of 2022 Universal Registration Document and 2022 Annual Report on Form 20-F

The Company’s 2022 Universal Registration Document for the year ended December 31, 2022, including the management report and the annual financial report, and its Annual Report on Form 20-F for the year ended December 31, 2022, will be filed with the “Autorité des Marchés Financiers” (AMF) and with the U.S. Securities and Exchange Commission (SEC), respectively, on March 27, 2023.

These documents will be accessible on the Investors section of the Company’s corporate website (www.erytech.com). In addition, the Universal Registration Document will be available on the website of the AMF (www.amf-france.org) and the Annual Report on Form 20-F will also be available on the website of the SEC (www.sec.gov). Printed copies of these documents will also be available free of charge, by sending a postal request to the registered offices of ERYTECH Pharma, Bâtiment Bioserra, 60 Avenue Rockefeller, 69008 in Lyon (France).

2023 Financial Calendar*

• Business Update and Financial Highlights for the First Quarter of 2023: May 9, 2023 (after U.S. market close), followed by a conference call & webcast on May 10, 2023 (2:30pm CET/8:30am ET)
• Shareholders’ Meeting: June 23, 2023 at 9.30am CET – Paris
• Business Update and Financial Highlights for the Second Quarter & First Half of 2023: September 11, 2023 (after U.S. market close), followed by a conference call & webcast on September 12, 2023 (2:30pm CET/8:30am ET)
• Business Update and Financial Highlights for the Third Quarter of 2023: November 6, 2023 (after U.S. market close), followed by a conference call & webcast on November 7, 2023 (2:30pm CET/8:30am ET)

(*): Information subject to change.

About ERYTECH

ERYTECH is a biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS® platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs.

On February 15 2023, ERYTECH announced its intended strategic combination with PHERECYDES to create a global player in extended phage. More detail can be found in the press release.

ERYTECH is listed on the Nasdaq Global Select Market in the United States (ticker: ERYP) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.

For more information, please visit www.erytech.com

CONTACTS

Forward-looking information

This press release contains forward-looking statements, forecasts and estimates with respect to the clinical results from and the development plans of eryaspase, business and regulatory strategy and anticipated future performance of ERYTECH and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. All statements contained in this press release other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding ERYTECH’s business and regulatory strategy and its evaluation of potential strategic transactions. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond ERYTECH’s control. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, the following: (1) the failure to achieve certain regulatory and commercial milestones; (2) the inability to maintain the listing of ERYTECH’s shares on the Nasdaq Global Select market and the Euronext regulated market; (3) changes in applicable laws or regulations; (4) the possibility that ERYTECH may be adversely affected by other economic, business and/or competitive factors; (5) the inability to agree to terms on a long-term supply agreement with Catalent; and (6) other risks and uncertainties indicated from time to time in ERYTECH’s regulatory filings. Further description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), the Company’s Securities and Exchange Commission (SEC) filings and reports, including in the Company’s 2021 Universal Registration Document (Document d’Enregistrement Universel) filed with the AMF on April 27, 2022 and in the Company’s Annual Report on Form 20-F filed with the SEC on April 28, 2022 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. ERYTECH disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in ERYTECH’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law.

Attachment

• ERYTECH_PR_Q4_FY_2022_EN_vf