On March 30, 2023 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the full year 2022, its recent business highlights, and a preview of select anticipated milestones (Press release, Surgimab, MAR 30, 2023, View Source [SID1234629625]).

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"In 2022, we achieved significant milestones in both our internal pipeline and strategic collaborations, while strengthening our management team with the appointment of Anne Borgman, M.D., as Chief Medical Officer," said Bill Newell, Sutro’s Chief Executive Officer. "We are delighted with the recent data updates for our lead candidate, luvelta, in advanced ovarian cancer and rare pediatric AML, and are excited to progress it into a planned registration-directed study in ovarian cancer in the second quarter of this year. As we look to the future, we remain confident in our ability to drive value and deliver on our mission to develop next-generation therapies that have the potential to transform the lives of cancer patients."

Recent Business Highlights and Select Anticipated Milestones

STRO-002, International Nonproprietary Name, "luveltamab tazevibulin" or abbreviated as "luvelta", FolRα-Targeting ADC: Luvelta is being studied in the clinic, in the U.S. and Europe, for patients with ovarian and endometrial cancers.

Sutro plans to initiate REFRaME, a Phase 2/3 registration-directed study for patients with platinum-resistant ovarian cancer, in the second quarter of 2023, as discussed with the U.S. Food and Drug Administration (FDA). Once results are collected on approximately 110 patients in the selected dose of the luvelta arm, Sutro plans to apply for accelerated approval based on overall response rate (ORR) as the primary endpoint. At the end of the trial, full approval can be sought based on progression free survival (PFS) as the primary endpoint, comparing the luvelta arm and the standard of care arm.
In January 2023, the company announced results from the luvelta Phase 1 dose-expansion study demonstrating that FolRα-selected patients–-defined as patients with TPS >25%–-experienced meaningful clinical benefit, with 43.8% ORR, median duration of response (DOR) of 5.4 months, and median PFS of 6.6 months for those receiving the higher starting dose of 5.2 mg/kg. The safety profile is generally consistent with prior data; asymptomatic neutropenia was the primary adverse event and no new safety signals were observed. Interim data from an exploratory cohort, with 5.2 mg/kg doses of luvelta together with prophylactic pegfilgrastim, appear to demonstrate reduced dose delays and lower incidences of Grade 3+ neutropenia.
Patients with CBFA2T3::GLIS2 (CBF/GLIS) AML, a highly refractory and uniformly fatal subtype of acute megakaryoblastic leukemia found exclusively in infants and young children, were treated with luvelta under compassionate use. During the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2022), an oral presentation was given by the investigator who aggregated the experiences of patients who were treated.
Additional ongoing clinical studies for luvelta include a combination study with bevacizumab for patients with advanced ovarian cancer and a dose-expansion study for patients with endometrial cancer. Translational work is ongoing to support an Investigational New Drug (IND) for the initiation of a non-small cell lung cancer (NSCLC) study, for which submission is planned in 2023.
STRO-001, CD74-Targeting ADC: The Phase 1 study for patients with B-cell malignancies has been completed in the global sites ex-Greater China and clinical studies in Greater China have been initiated.

Sutro has completed the Phase 1 dose-escalation study in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM), after reaching a maximum tolerated dose (MTD). Sutro plans to leverage the clinical data produced by its partner BioNova Pharma (BioNova) in Greater China to make decisions regarding further clinical development, based on a prioritization assessment.
BioNova is advancing clinical development of BN301 (STRO-001) for patients with hematological malignancies in Greater China. In February 2023, BioNova announced that the first patient had been dosed in the Phase 1 clinical study of BN301 (STRO-001) for the treatment of advanced B-cell Non-Hodgkin’s Lymphoma (NHL).
Additional Pipeline Programs: A Sutro Research Forum, held in 2022, highlighted STRO-003 and Sutro’s emerging research portfolio.

STRO-003 is an advanced ADC that has been designed to target ROR1, takes advantage of innovative linker-warhead technology and features eight precisely placed β-Glucuronidase-cleavable linkers attached to next-generation exatecan warheads, known for their ability to inhibit topoisomerase-1 (TOPO-1) and cause DNA disruption.
STRO-003 has demonstrated in NSCLC and breast cancer patient-derived xenograft models strong cell-killing activity in low and heterogeneous expressing tumors. STRO-003 has exhibited promising tolerability in preclinical studies involving rodents and non-human primates, potentially reducing lung toxicity, a concern that is commonly associated with TOPO-1 class payload ADCs. Preparations are underway for IND enabling studies for STRO-003, which we expect will be completed in the first quarter of 2024.
Sutro provided details on its product and process design, which enables its emerging portfolio including novel therapeutic modalities—for example, a single antibody which can be conjugated site-specifically to deliver two different payloads with synergistic mechanisms.
Collaboration Updates: Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has generated from collaborators an aggregate of approximately $621 million in payments through December 31, 2022, including equity investments.

In December 2022, Sutro and Vaxcyte expanded upon a nearly decade-long relationship through a new agreement, under which Vaxcyte acquired an option to access expanded rights to develop and manufacture cell-free extract, among other rights, and includes a $22.5 million upfront payment and, upon exercise of the option, up to an additional $135 million in option exercise and contingent payments. In October 2022, Vaxcyte reported positive topline data from the Phase 1/2 proof-of-concept study of its 24-valent pneumococcal conjugate vaccine candidate (VAX-24) under investigation for the prevention of invasive pneumococcal disease in adults aged 18-64. Under an existing license agreement with Vaxcyte, Sutro is eligible to receive four percent (4%) royalties on worldwide net sales of any licensed vaccine candidates for human health use, including VAX-24.
Sutro’s collaboration with Astellas on the discovery of immunostimulatory antibody-drug conjugates (iADCs) for three targets is ongoing, for which Sutro receives financial support for its research efforts, potential milestone payments and royalties, and has an option to co-develop and co-commercialize product candidates in the U.S.
Sutro is manufacturing initial drug supply for the clinical development of Merck’s MK-1484, currently in a Phase 1; and clinical trial materials for Bristol Myers Squibb’s (BMS) CC-99712, a BCMA-targeting ADC for treatment of multiple myeloma, currently in Phase 1.
Sutro is providing clinical drug supply to BioNova for clinical studies for BN301 (STRO-001) in Greater China. Sutro is currently supporting Tasly Biopharmaceuticals (Tasly) for initiation of clinical development activities and an IND filing in Greater China for STRO-002 and will provide initial clinical drug supply.
Corporate Updates: Sutro strengthened and continues to build a world-class leadership team through the appointment of a new Chief Medical Officer and internal promotions.

Anne Borgman, M.D., joined Sutro as Chief Medical Officer in February 2023 overseeing the Clinical Development & Regulatory teams, with focus on the development of luvelta and clinical strategy for Sutro’s proprietary pipeline, in addition to being a member of Sutro’s Senior Management Team.
Sutro bolstered the Senior Management Team with the promotion of Brunilda Shtylla to Chief Business Officer, who leads Business Development. Devendra Luhar was promoted to SVP, Manufacturing & San Carlos Facility, and Carlos Lugo Ponce was promoted to SVP, Quality Control & Quality Assurance.
Full Year 2022 Financial Highlights

Cash, Cash Equivalents and Marketable Securities
As of December 31, 2022, Sutro had cash, cash equivalents and marketable securities of $302.3 million, as compared to $287.3 million as of September 30, 2022, and approximately 0.7 million shares of Vaxcyte common stock with a fair value of $32.0 million, which together provide a projected cash runway into the second half of 2024, based on current business plans and assumptions.

Unrealized Gain from Increase in Value of Vaxcyte Common Stock
The non-operating, unrealized gain of $12.1 million for the year 2022 was due to the increase since December 31, 2021 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’s statements of operations. Sutro sold approximately 1.1 million shares of Vaxcyte common stock during 2022.

Revenue
Revenue was $67.8 million for the year ended December 31, 2022, as compared to $61.9 million for the same period in 2021, with the 2022 amount related principally to recognition of the upfront payment from Tasly, the milestone payment from Merck, and the Astellas, BMS, and EMD Serono collaborations and BioNova agreement. Future collaboration and license revenue under existing agreements and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Operating Expenses
Total operating expenses for the year ended December 31, 2022 were $196.7 million, as compared to $160.4 million for the same period in 2021. The year 2022 includes non-cash expenses for stock-based compensation of $26.3 million and depreciation and amortization of $5.7 million, as compared to $23.2 million and $4.8 million, respectively, in the comparable 2021 period. Total operating expenses for the year ended December 31, 2022 were comprised of research and development expenses of $137.2 million and general and administrative expenses of $59.5 million, which are expected to increase in 2023 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.

On March 30, 2023 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2022 and provided a business update (Press release, Savara, MAR 30, 2023, View Source [SID1234629624]).

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"Enrollment in the pivotal Phase 3 IMPALA-2 trial remains on-track, and we continue to anticipate reporting top line safety and efficacy data by the end of 2Q 2024," said Matt Pauls, Chair and CEO, Savara. "As we approach the milestone of enrollment completion, I am proud of the team’s ability to advance the molgramostim development program during the headwinds of the COVID pandemic. That operational focus will extend to the launch of a global aPAP market development campaign in the second half of the year. Finally, in 2022 we maintained our track record of fiscal discipline and believe we are fully capitalized through 2025."

Fourth Quarter Financial Results (Unaudited)

Savara’s net loss for the fourth quarter of 2022 was $10.3 million, or $(0.07) per share, compared with a net loss of $11.3 million, or $(0.07) per share, for the fourth quarter of 2021.

Research and development expenses were $7.6 million for the fourth quarter of 2022, which were equivalent to the fourth quarter of 2021.

General and administrative expenses for the fourth quarter of 2022 and 2021 were $3.2 million and $3.0 million, respectively.

As of December 31, 2022, the Company had cash, cash equivalents and short-term investments of $125.9 million.

Fiscal Year 2022 Financial Results

The Company’s net loss for the year ended December 31, 2022 was $38.2 million, or $(0.25) per share, compared with a net loss of $43.0 million, or $(0.32) per share for the year ended December 31, 2021.

Research and development expenses decreased $1.1 million, or 3.8%, to $27.9 million for the year ended December 31, 2022 from $29.0 million for the year ended December 31, 2021. The decrease was primarily related to the termination of the vancomycin study during the year ended December 31, 2020, with the study close-out completed in the year ended December 31, 2021.

General and administrative expenses decreased $1.4 million, or 11.5%, to $10.9 million for the year ended December 31, 2022 from $12.4 million for the year ended December 31, 2021. The decrease was primarily due to the reduction of personnel and overhead costs from the closure of the Company’s Denmark office and Danish activities.

On March 30, 2023 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three and 12 months ended December 31, 2022, and provided operating and partner program updates (Press release, OmniAb, MAR 30, 2023, View Source [SID1234629623]).

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"Following the closing of the spin-off and business combination transactions last November, OmniAb is well-positioned for continued growth by offering cutting-edge antibody discovery platforms and complementary technologies," said Matt Foehr, Chief Executive Officer of OmniAb. "Leveraging a rich heritage of innovations designed to facilitate the discovery of novel therapeutics including those targeting ion channels and transporters, OmniAb is at the forefront of antibody discovery with the industry’s only four-species platform facilitating fully human and bispecific antibody discovery, supported by a highly dedicated staff and world-class scientific and business advisors.

"2022 was another terrific year for the business as we added a record-high 13 new partnerships and our partners continued to increase their number of programs. We are excited about the future as we leverage our highly scalable business model and invest in our technologies," he added. "We are planning to introduce new technologies and innovations later this year as we serve current partners and add new ones, while enhancing our best-in-class technology stack."

On November 1, 2022, OmniAb completed a spin-off from Ligand Pharmaceuticals Incorporated (NASDAQ: LGND), resulting in OmniAb becoming an independent publicly traded company. Financial results prior to November 1, 2022, are presented on a carve-out basis derived from Ligand’s historical accounting records, as if OmniAb were an independent company.

Fourth Quarter 2022 Financial Results

Revenue for the fourth quarter of 2022 was $35.3 million, compared with $15.3 million for the same period in 2021, with the increase primarily attributable to the recognition of a $25.0 million milestone payment related to the first commercial sale of TECVAYLI (teclistamab) in the U.S. OmniAb expects to recognize a $10.0 million milestone payment related to the first commercial sale in the European Union (EU) in 2023.

Research and development expense was $12.9 million for the fourth quarter of 2022, compared with $11.0 million for the same period in 2021, with the increase primarily due to investments in facilities, headcount and technology innovation. General and administrative expense was $10.2 million for the fourth quarter of 2022, compared with $4.3 million for the same period in 2021, with the increase primarily due to higher headcount related to becoming an independent publicly traded company.

Net income for the fourth quarter of 2022 was $6.8 million, or $0.07 per diluted share, compared with a net loss of $3.1 million, or $0.04 per share, for the same period in 2021.

Full Year 2022 Financial Results

Revenue for 2022 was $59.1 million, compared with $34.7 million for 2021, with the increase attributable to the recognition of the $25.0 million TECVAYLI (teclistamab) milestone payment following the first commercial sale in the U.S. and royalty revenue from our partners’ sales of zimberelimab and sugemalimab.

Research and development expense for 2022 was $48.4 million, compared with $39.2 million for 2021, with the increase primarily due to continued investments in facilities, headcount and technology innovation. General and administrative expense for 2022 was $24.9 million, compared with $16.9 million for 2021, with the increase primarily due to expenses associated with the spin-off and business combination, as well as headcount-related expenditures as we prepared to become an independent public company.

Net loss for 2022 was $22.3 million, or $0.26 per share, compared with a net loss of $27.0 million, or $0.33 per share, for 2021. Cash used to fund operating activities was $3.6 million for 2022.

As of December 31, 2022, OmniAb had cash, cash equivalents and short-term investments of $88.3 million. Subsequent to the close of the year, in January 2023 OmniAb received $35.0 million in milestone payments from Janssen related to TECVAYLI (teclistamab). The current cash, cash equivalents and short-term investments balance, along with the cash the Company generates from operations are expected to be sufficient to fund operations for the foreseeable future. The Company expects its 2023 year-end cash, cash equivalents and short-term investments balance to be slightly higher than year-end 2022.

Fourth Quarter 2022 and Recent Business Highlights

In 2022, the company signed 13 new licenses, including one in the fourth quarter with the Wistar Institute. In addition, during the quarter three new programs entered the clinic: M9140 (Merck KGaA), an antibody-drug conjugate anti-CEACAM5 in advanced solid tumors; GEN1053 (Genmab/BioNTech), a hexabody anti-CD27 in malignant solid tumors; and JNJ-79635322 (Janssen), a trispecific in relapsed or refractory multiple myeloma. As of December 31, 2022, the company had 69 active partners with 26 OmniAb-derived programs in clinical development or being commercialized, and a total of 291 programs being pursued or commercialized.

During the quarter, OmniAb entered into an agreement with mAbsolve Ltd. for STR, mAbsolve’s Fc-silencing platform technology. The agreement provides OmniAb with exclusive, sublicensable right to incorporate the STR technology with antibodies that have been generated using OmniAb’s antibody discovery platform.

Fourth quarter 2022 and recent partner highlights include the following:

TECVAYLI (teclistamab)

Janssen Biotech, Inc. received approval from the U.S. Food and Drug Administration for TECVAYLI (teclistamab) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
Batoclimab

Immunovant announced initiation of a Phase 3 clinical trial of batoclimab in thyroid eye disease and a Phase 2b clinical trial in chronic inflammatory demyelinating polyneuropathy.
Sugemalimab

EQRx announced the Marketing Authorization Applications for sugemalimab in combination with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) were accepted for review by both the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the European Medicines Agency for the EU.
CStone announced the National Medical Products Administration of China accepted the supplemental new drug application (sNDA) for sugemalimab in combination with chemotherapy as a first-line treatment of unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma. The sNDA is based on the GEMSTONE-303 study, in which sugemalimab in combination with chemotherapy as a first-line treatment for unresectable locally advanced or metastatic gastric adenocarcinoma/gastro-esophageal junction adenocarcinoma with PD-L1 expression ≥5% met one of its primary endpoints, progression-free survival. CStone also announced topline results from the GEMSTONE-304 study, in which sugemalimab in combination with chemotherapy as a first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma met its primary endpoints.
Zimberelimab

Gilead Sciences and Arcus Biosciences announced positive results from the fourth interim analysis of the ARC-7 study in patients with first-line, metastatic NSCLC with PD-L1 tumor proportion score ≥50% without epidermal growth factor receptor or anaplastic lymphoma kinase mutations. ARC-7 is a Phase 2 multicenter, three-arm, randomized, open-label study evaluating the combinations of Fc-silent anti-TIGIT monoclonal antibody domvanalimab plus anti-PD-1 monoclonal antibody zimberelimab (doublet) and domvanalimab plus zimberelimab and etrumadenant, an A2a/b adenosine receptor antagonist (triplet), versus zimberelimab monotherapy.
Conference Call

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (888) 886-7786 using the conference ID 43857264. Slides, as well as the live and replay webcast of the call, are available at View Source

On March 30, 2023 Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, reported financial results for the year ended December 31, 2022 and provided a company update (Press release, Daré Bioscience, MAR 30, 2023, View Source [SID1234629622]).

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"Daré announced a number of positive developments related to our existing portfolio since the beginning of 2022 which serve to benefit all of our stakeholders. We entered into an exclusive global license agreement with Organon for commercialization of our first FDA-approved product, XACIATO. We completed two Phase 1/2 clinical studies in Australia and announced positive topline data for both. We received FDA approval of our IDE application for Ovaprene, allowing us to conduct a single arm, open-label pivotal contraceptive efficacy study and we hosted an investigator meeting. Finally, we completed subject screening for our exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% for female sexual arousal disorder and are targeting the second quarter of 2023 to announce topline data. We seek to continue the progress made over the past fifteen months by moving these candidates forward in development in 2023 and 2024," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.

"During 2022, we received $24.1 million in non-dilutive funding which included a $10.0 million cash payment upon the the license agreement with Organon for XACIATO becoming effective, $13.3 million received under grants, and a research and development cash rebate of $0.8 million from the Australian government for clinical work performed in Australia in 2021. Daré will continue to explore ways to operate our business efficiently and to fund our portfolio in a manner we believe will be favorable to our shareholders," added Ms. Johnson

"Our focused efforts to deliver differentiated innovation in women’s health have resulted in 12 development programs across 9 distinct indications, with more than 5 milestone events anticipated in 2023, 3 products in or nearing phase 3 development, 2 potentially transformational collaborations with leaders in women’s health product commercialization, Bayer and Organon, and 1 FDA approved product, XACIATO. Strategic additions to our portfolio in 2022 include global rights to a promising, antimicrobial glycerol monolaurate, which has the potential to be a first-in-category multi-target antimicrobial for vaginal administration. We also added two new candidates to our portfolio—DARE-PDM1 and DARE-LBT—that leverage our proprietary vaginal thermosetting hydrogel technology used in XACIATO. We commenced a Phase 1 study in the first quarter of 2023 for DARE-PDM1, a candidate that delivers the NSAID diclofenac vaginally for the treatment of primary dysmenorrhea, and we received grant funding for DARE-LBT to assess our proprietary hydrogel technology’s potential to deliver live biotherapeutics to support vaginal health. The ability to leverage a platform technology that has recently undergone successful preclinical and clinical testing and regulatory review could offer both time and cost advantages in the development of new candidates to address meaningful unmet needs in women’s health."

2022 Year and Q1 2023 In Review

Period Portfolio Asset Development /Outcome
Q1-2022
March XACIATOTM Announced exclusive global commercialization agreement with Organon
Q2-2022
April DARE-HRT1 Commenced Phase 1/2 study
May DARE-ADARE 204 & 214 Received $249,000 NIH grant award
June XACIATOTM Organon global commercialization agreement became effective; $10 M received in July
Q3-2022
July DARE-LARC1 Received $8 million of grant funding
August GML, antimicrobial glycerol monolaurate Signed exclusive global technology license with Hennepin Life Sciences
August Sildenafil Cream, 3.6% Announced expected timing for completion of enrollment of Phase 2b RESPOND clinical study based on interim analysis
Q4-2022
October DARE-HRT1 Announced positive topline efficacy data from Phase 1/2 study
October Ovaprene Received IDE approval for pivotal study
November Sildenafil Cream, 3.6% Completed subject screening for exploratory Phase 2b RESPOND clinical study
November DARE-LBT1 Received $585,000 grant funding
November DARE-VVA1 Announced positive topline data from Phase 1/2 study
December DARE-LARC1 Received $4.4 million grant funding
December Ovaprene Investigator kick-off meeting with NICHD for pivotal study
Q1-2023
January DARE-HRT1 Announced positive topline pharmacokinetic (PK) data from Phase 1/2 study
February DARE-PDM1 Commenced Phase 1 study

Portfolio Summary

XACIATOTM (clindamycin phosphate) vaginal gel, 2%:

A clear, colorless, viscous gel to be administered once intravaginally as a single dose for the treatment of bacterial vaginosis in female patients 12 years of age and older. Please click here for full prescribing Information.

3Q-2022: $10.0 million cash payment received under license agreement with Organon to commercialize XACIATO
4Q-2022: Organon market access team began meeting with customers and preparing for a U.S. launch
2Q-2023: First commercial sale expected, triggering a $2.5 million milestone to Daré
Bacterial vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 23 million women in the U.S.1 The condition results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor and discharge. In addition to being the most common type of vaginal infection in women of reproductive age and having bothersome symptoms, bacterial vaginosis has been associated with certain increased health risks, including pre-term labor and infertility.1, 2

Ovaprene:

A novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare.

4Q-2022: FDA approved an Investigational Device Exemption (IDE) application for a single arm, open-label pivotal contraceptive efficacy study over 12-months (13 menstrual cycles) and provided additional study design considerations
4Q-2022: Investigator meeting held (with the NICHD) for the pivotal Phase 3 clinical study
Mid-2023: Anticipated initiation of subject recruitment for the pivotal Phase 3 clinical study
The planned pivotal Phase 3 clinical study will be conducted under a Collaborative Research and Development Agreement with the U.S. Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH).

Sildenafil Cream, 3.6%:

A proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra, for topical administration to treat female sexual arousal disorder.

4Q-2022: Completed subject screening for exploratory Phase 2b RESPOND clinical study
2Q-2023: Topline data announcement targeted for Phase 2b RESPOND clinical study
DARE-HRT1:

A unique, investigational intravaginal ring (IVR) designed to deliver bio-identical estradiol and progesterone continuously over a 28-day period for the treatment of menopausal symptoms, including moderate to severe vasomotor symptoms, as part of a menopausal hormone therapy regimen.

4Q-2022: Positive topline efficacy data reported from Phase 1/2 clinical study
1Q-2023: Positive topline PK data reported from Phase 1/2 clinical study, and anticipated plans to progress to a single Phase 3 study announced
DARE-VVA1:

A proprietary, investigational formulation of tamoxifen for intravaginal administration to treat vulvar and vaginal atrophy in women without the use of hormones.

3Q-2021: Phase 1/2 clinical study initiated in Australia
4Q-2022: Positive topline safety, tolerability, PK and pharmacodynamics data reported from Phase 1/2 clinical study
Financial Highlights for the Year ended December 31, 2022

Cash and cash equivalents: $34.7 million at December 31, 2022, compared to $51.7 million at December 31, 2021.
General and administrative expenses: $11.2 million in fiscal 2022 as compared to $8.4 million in the prior year, with the current year’s increase primarily attributable to an increase in professional services expenses, stock-based compensation expense, personnel costs, general corporate overhead expenses, and expenses related to commercial-readiness activities for XACIATO.
Research and development expenses: $30.0 million in fiscal 2022 as compared to $30.6 in the prior year. The current year’s R&D activities across our entire portfolio of 12 development candidates primarily reflected expenses related to the ongoing Sildenafil Cream, 3.6% exploratory Phase 2b RESPOND clinical trial, manufacturing and regulatory affairs activities related to Ovaprene, costs related to development activities for XACIATO, and costs related to development activities for our preclinical programs and Phase 1 and Phase 1-ready programs.
1 View Source and View Source
2 View Source

On March 30, 2023 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported financial results for the fourth quarter and full-year ended December 31, 2022, and provided a corporate update (Press release, Theriva Biologics, MAR 30, 2023, View Source [SID1234629621]).

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"In 2022, we delivered on key milestones that further validate the value of Theriva’s oncology-focused platform, advanced our systemically administered lead oncolytic adenovirus, VCN-01, and with cash runway into the third quarter of 2024, we believe we are well positioned to propel our clinical development program forward," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "The dosing of the first patient in VIRAGE, our Phase 2b trial of VCN-01 in patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC), as well as the Phase 1 trial of VCN-01 in patients with brain tumors, represent important steps in our pursuit to address unmet needs for difficult-to-treat cancers. Now, a key priority is to build on our compelling Phase 1 outcomes and generate clinical data that establish VCN-01’s differentiated mechanism of action, and potential synergistic clinical benefit in combination with chemotherapy and immunotherapy in a range of clinical indications. We will also leverage our discovery platform to identify the next generation of potent OV products."

Recent Program Highlights and Anticipated Milestones:

VCN-01:

In January 2023, the first patient was dosed in VIRAGE, the randomized, controlled, multicenter, open-label Phase 2b trial of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy in newly diagnosed metastatic PDAC patients. The first patient was dosed in Spain and the trial is expected to enroll 92 adults at sites across the US and EU.
In January 2023, the first patient was dosed in the investigator sponsored clinical trial of VCN-01 in patients with high-grade brain tumors who are scheduled for surgical resection. The trial is being conducted at St. James’s University Hospital, United Kingdom, in collaboration with the University of Leeds. If the results show that intravenous VCN-01 gains entry to brain tumors that are otherwise only accessible through surgery, this could be transformative for patients by providing a potential systemic line of treatment that may minimize or eliminate complicated brain surgery.
Anticipated milestones:
Hold a pre-IND meeting with the FDA (H2 2023) to discuss the clinical development and potential registration pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma.
Present additional data from the study of VCN-01 in combination with durvalumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (H2 2023).
SYN-004 (ribaxamase):

In February 2023, presented blinded safety and pharmacokinetic (PK) data from the ongoing Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD). SYN-004 appeared to be well tolerated in HCT patients treated with IV meropenem and SYN-004 was not detected in blood samples from the majority of the evaluable patients. These data were presented at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR.
In November 2022, announced the first patient was dosed in the second cohort of the SYN-004 study in allo-HCT patients.
Anticipated milestones:
Complete the second cohort of our Phase 1b/2a clinical study of SYN-004 for the prevention of acute graft-versus-host-disease in bone marrow transplant patients (Q1 2024).
Fourth Quarter and Full-Year Ended December 31, 2022 Financial Results

General and administrative expenses increased to $9.9 million for the year ended December 31, 2022, from $6.5 million for the year ended December 31, 2021. This increase of 50.8% is primarily comprised of increased expense related to the fair value of the contingent consideration, higher insurance costs, additional salary and benefits related to new headcount, public relations expenses, and VCN administrative expenses not included in the prior year, offset by a decrease in consulting and legal costs related to the VCN acquisition. The charge relating to stock-based compensation expense was $0.4 million for the year ended December 31, 2022, compared to $0.3 million for the year ended December 31, 2021. In addition, we expect general and administrative expenses to increase as we increase headcount and related overhead due to the VCN acquisition.

Research and development expenses increased to $11.7 million for the year ended December 31, 2022, from $7.8 million for the year ended December 31, 2021. This increase of 50% is primarily the result of increased clinical trial expenses related to VCN-01 not incurred in the prior year, offset by lower clinical and manufacturing expenses related to our Phase 1a clinical trial of SYN-020 and expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients. We anticipate research and development expense to increase as we continue enrollment in our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, and our ongoing Phase 1 clinical trial in retinoblastoma, expand GMP manufacturing activities for VCN-01, and continue supporting our VCN-11 and other preclinical and discovery initiatives. Research and development expenses also include a charge relating to non-cash stock-based compensation expense of $112,000 for the year ended December 31, 2022, compared to $76,000 for the year ended December 31, 2021. In addition, we expect research and development expenses to increase as we incur higher clinical program costs for our VCN product candidates.

Other income was $471,000 for the year ended December 31, 2022, compared to other income of $6,000 for the year ended December 31, 2021. Other income for the year ended December 31, 2022 and is primarily comprised of interest income of $512,000 offset by an exchange loss of $41,000. Other income for the year ended December 2021 was primarily comprised of interest income.

Cash and cash equivalents totaled $41.8 million as of December 31, 2022, compared to $67.3 million as of December 31, 2021.

Conference Call

Theriva Biologics will host a conference call on Thursday, March 30, 2022, at 8:30 a.m. ET to review the full-year 2022 operational highlights and financial results. Individuals may participate in the live call via telephone by dialing 1-877-451-6152 (domestic) or 1-201-389-0879 (international) and using the conference ID: 13736047. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via the "Investors" section of the company’s website, View Source, under "Events" or by clicking here, for 90 days after the call.