HST-001

Strengthened Balance Sheet with $25.3 Million of Gross Proceeds from Financings and Warrant Exercises Initiation of Phase 1 Study of Emricasan in Symptomatic COVID-19 Patients Anticipated in the First Quarter of 2021 HST 003 Trial Initiation for Cartilage Regeneration in the Knee Anticipated in the Second Quarter of 2021 Appointment of Industry Leader Dr. Susan Windham-Bannister to Board of Directors SAN DIEGO, March 11, 2021 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, today reported financial results for the fourth quarter and year ended December 31, 2020 and provided an update on its clinical pipeline and other corporate developments. “Throughout 2020 and into 2021, we have transformed Histogen into a well-capitalized public company with a focus on advancing our novel pipeline in multiple therapeutic indications and building the strength and diversity of our team and board of directors,” said Richard W. Pascoe, President and Chief Executive Officer. Looking ahead, we will continue to focus on clinical execution with HST-001 in androgenic alopecia, HST-003 in cartilage repair and emricasan in COVID-19 with the overarching goal of restoring function and enhancing the lives of patients as we seek to drive value for our shareholders. Finally, I want to welcome Dr. Susan Windham-Bannister to our Board of Directors. Sue brings to our board relevant industry experience with a focus on strategic growth which will serve Histogen well during this pivotal time in our corporate evolution.” Highlights from the Fourth Quarter and Year Ended 2020 and Business Updates Fourth Quarter and Full-Year 2020 Financial Highlights Fourth Quarter Ended December 31, 2020 and 2019 Product and Service Revenues for the three months ended December 31, 2020 and 2019 were $0.5 million and $1.6 million, respectively. The decrease of $1.1 million was primarily due to a decrease in fulfillment of supply orders of CCM to Allergan. Cost of revenues for the three months ended December 31, 2020 and 2019, we recognized cost of product revenue of $0.3 million and $1.0 million, respectively. The decrease of $0.7 million for the three months ended December 31, 2020 as compared to the three months ended December 31, 2019 was commensurate with the decrease in product sales to Allergan as well as a write-off of inventory of $0.2 million related to the termination of the supply agreement with Edge Systems LLC in 2019. Research and development expenses for the three months ended December 31, 2020 and 2019 were $1.9 million and $1.4 million, respectively. The increase of $0.5 million for the three months ended December 31, 2020 as compared to the three months ended December 31, 2019 was primarily due to increases related to expanded development costs of our product candidates and increases in personnel related expenses due to changes in duties and responsibilities of existing personnel. General and administrative expenses for the three months ended December 31, 2020 and 2019 were $1.8 million and $1.6 million, respectively. The $0.2 million increase for the three months ended December 31, 2020 as compared to the three months ended December 31, 2019 was primarily due to increases in insurance, rent and legal and accounting fees, offset by decreases in personnel related expenses due to changes in duties and responsibilities of existing personnel. Twelve Months Ended December 31, 2020 and 2019 Revenues For the years ended December 31, 2020 and 2019, we recognized license revenues of $0.9 million and $7.5 million, respectively. The $7.5 million recognized in the year ended December 31, 2019 related to an upfront payment received in connection with the execution of the 2019 Allergan Agreement amendment. In the year ended December 31, 2020, we received a $1.0 million upfront payment in connection with an amendment to the 2019 Allergan Agreement of which approximately $28,000 remains in deferred revenue at December 31, 2020. For the years ended December 31, 2020 and 2019, we recognized product revenues of $0.8 million and $3.4 million, respectively. The decrease of $2.6 million for the year ended December 31, 2020, as compared to the year ended December 31, 2019 was primarily due to a decrease of supply orders of CCM to Allergan and one additional customer. Grant revenue for the years ended December 31, 2020 and 2019 was $0 and $0.2 million, respectively, all of which was related to an NSF research grant awarded to us in 2017 and resulted from the acceptance of milestone reports in 2019. For the years ended December 31, 2020 and 2019, we recognized professional services revenue of $0.3 million and $0.4 million, respectively. Cost of Revenues For the years ended December 31, 2020 and 2019, we recognized cost of product revenue of $0.7 million and $1.9 million, respectively. The decrease of $1.2 million for the year ended December 31, 2020 as compared to the year ended December 31, 2019 was commensurate with the decrease in product sales in 2020, coupled with a $0.2 million write-off of inventory. For the years ended December 31, 2020 and 2019, we recognized costs of professional services of $0.3 million. In-process research and development expenses increased $4.9 million for the year ended December 31, 2020 as compared to the year ended December 31, 2019. In the year ended December 31, 2020, we incurred $7.1 million for in-process research and development acquired in connection with the Merger and in the year ended December 31, 2019, we incurred $2.3 million for in-process research and development related to the acquisition of HST-003 and HST-004 from PUR. Research and development expenses for the years ended December 31, 2020 and 2019 were $6.2 million and $4.1 million, respectively. The increase of $2.1 million for the year ended December 31, 2020, as compared to the year ended December 31, 2019 was primarily due to expanded development costs of our product candidates HST-001 and HST-003. General and administrative expenses for the years ended December 31, 2020 and 2019 were $6.6 million and $6.2 million, respectively. This increase of $0.4 million for the year ended December 31, 2020 was primarily due to increases in insurance and other professional fees of $1.2million, offset by a decrease in success-based fees related to license revenue received of approximately $0.8 million. Cash and cash equivalents as of December 31, 2020 were $6.8 million. The $6.8 million is exclusive of gross proceeds of $14 million from a public offering that we closed in January 2021 and gross proceeds of $6.8 million from the exercise of outstanding warrants in connection with the January 2021 public offering. Histogen believes that its existing cash and cash equivalents and cash inflow from operations will be sufficient to meet Histogen’s anticipated cash needs into the second quarter of 2022. About Histogen Inc. Histogen Inc. is a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function. Histogen’s innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen’s proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss Histogen’s future operations and its ability to successfully initiate and complete clinical trials, obtain clinical trial data and achieve regulatory milestones and related timing, including those related to the commencement of the planned HST-001 clinical trial for androgenic alopecia in men, approval of a HST-003 IND for the planned Phase 1/2 clinical trial for regeneration of cartilage in the knee and the commencement of such trial and the commencement of the planned Phase 1 study of emricasan for the treatment of COVID-19 and receipt of top-line data; the nature, strategy and focus of Histogen’s business; the sufficiency of Histogen’s cash resources and Histogen’s ability to achieve value for its stockholders; the sufficiency of Amerimmune’s cash resources and its ability to commence, enroll and complete the planned Phase 1 study of emricasan and achieve value for Histogen’s stockholders; and the development and commercial potential and potential benefits of any of Histogen’s product candidates, such as HST-001, and HST-003, and the Collaborative Development and Commercialization Agreement with Amerimmune and any other collaboration agreements. Histogen may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on Histogen’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Histogen that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of Histogen’s product candidates, including potential delays in the commencement, enrollment and completion of clinical trials, such as the planned HST-001 clinical trial for androgenic alopecia in men, approval of the HST-003 IND for the planned Phase 1/2 clinical trial of HST-003 for regeneration of cartilage in the knee and Amerimmune’s ability to further develop emricasan for the treatment of COVID-19, including the complexity and length of studies required to commercialize emricasan for COVID-19 and potential delays in the commencement, enrollment and completion of clinical trials, such as the planned emricasan Phase 1 study for the treatment of COVID-19; Histogen’s dependence on its collaboration partner, Amerimmune, to carry out the development of emricasan and the potential for delays in the timing of regulatory approval; competition in the COVID-19 market and other markets in which Histogen and its collaboration partner operate; the potential that earlier clinical trials and studies of Histogen’s product candidates may not be predictive of future results; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm Histogen’s financial condition and increase its costs and expenses; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including those risks discussed in Histogen’s filings with the Securities and Exchange Commission. Except as otherwise required by law, Histogen disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise. *The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702, is the awarding and administering acquisition office. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702, is the awarding and administering acquisition office. CONTACT: Susan A. KnudsonExecutive Vice President & CFO Histogen Inc. ir@histogen.com HISTOGEN INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except share and per share amounts) HISTOGEN INC. AND SUBSIDIARIESCONSOLIDATED BALANCE SHEETS(in thousands, except share and per share amounts)

It was a busy week for clinical trial announcements. Here’s a look. COVID-19-Related All India Institute of Medical Sciences (AIIMS) indicated that Bharat Biotech’s COVID-19 vaccine, Covaxin, may offer immunity for nine to 12 months, based on mathematical models. The vaccine was already approved before the release of Phase III data and was used to inoculate healthcare workers during the Phase I trial. Clene Nanomedicine initiated a Phase II trial of CNM-ZnAg liquid solution in acutely symptomatic, non-hospitalized COVID-19 patients. The primary endpoint will evaluate the rate of decreased hospitalizations at day 28. CNM-ZnAg is a proprietary zinc-silver ionic solution that has both antiviral and antibacterial properties as well as immune-boosting properties. Oxford University announced it began testing its COVID-19 vaccine in children as young as six years of age. The study will include 300 children ages 6 to 17, with 240 receiving the vaccine co-developed with AstraZeneca. The remaining volunteers will receive a control meningitis vaccine that has been proven safe in children but is believed to mimic side effects of the COVID-19 vaccine. Mesoblast Limited published results on the first two children treated with its mesenchymal stromal cell (MSC) product candidate, remestemcel-L for multisystem inflammatory syndrome (MIS-C) associated with COVID-19. MIS-C is a potentially life-threatening inflammatory conditions involving multiple critical organs and their vasculature. It is linked to previous, instead of active COVID-19 infection. PTC Therapeutics initiated the second stage of the Phase II/III FITE19 clinical trial of PTC299 in COVID-19 patients. PTC299 is an oral drug with dual mechanisms of action that potentially inhibits viral replication and attenuates the uncontrolled inflammatory response post-infection. The drug targets dihydroorotate dehydrogenase (DHODH). Altimmune received the go-ahead from the FDA for its Phase I trial of AdCOVID, its single-dose, intranasal COVID-19 vaccine. It will test the safety and immunogenicity of the vaccine in up to 180 healthy adult volunteers ages 18 to 55. Pharma Mar SA received approval in the UK to initiate its Phase III NEPTUNO trial of Aplidin (plitidepsin) for hospitalized patients with moderate COVID-19. The trial is expected to run in 12 countries but was first authorized in the UK. It hopes to enroll more than 600 patients. Aplidin blocks the eEF1A protein, which SARS-CoV-2 uses to replicate and infect other cells. Biophytis SA began patient recruitment in France and Belgium for Part 2 of its COVA Study assessing Sarconeos for acute respiratory failure associated with COVID-19. Sarconeos is an oral, small molecule being developed for sarcopenia and severe respiratory aspects of COVID-19, as well as in a pediatric formulation for Duchenne muscular dystrophy (DMD). EmitBio announced statistically significant efficacy results from its Phase I/II trial of its medical device that directs precise wavelengths of safe, visible light targeted to the back of the throat and surrounding tissues. The device was designed for self-treatment of COVID-19 in an at-home setting. Diffusion Pharmaceuticals completed and announced topline data from its Phase Ib trial of its diffusion-enhancing therapeutic, trans sodium crocetinate, in hospitalized COVID-19 patients with confirmed hypoxemia. The primary endpoint was safety and tolerability, with secondary endpoints being pharmacokinetic measurement of trans sodium crocetinate levels after dosing, relative improvements in blood oxygen levels, and other clinical measures associated with COVID-19. Pfizer and BioNTech dosed the first patients in a clinical trial of 4,000 women in the late stages of pregnancy yesterday. The two companies will run the Phase II trial for 350 volunteers between 27 and 34 weeks’ gestation to confirm safety before moving into the Phase III portion for women between 24 and 34 weeks of pregnancy. AstraZeneca and Johnson & Johnson also plan to run trials in the coming months on pregnant women. CMTx Biotech received a $315,000 Clinical Trial Planning Grant from the NIH’s National Center for Advancing Translational Sciences to finalize a Phase II trial of incyclinide. The drug is its candidate for treatment of hospitalized COVID-19 patients. The drug is a non-antimicrobial tetracycline formulation, which is the specialty of CMTx. “Incyclinide has already been shown to be highly effective in a number of animal models of acute respiratory distress syndrome across several species,” noted Lorne Golub, co-founder of CMTx and SUNY Distinguished Professor of Oral Biology and Pathology. Non-COVID-19-Related Merck presented new data from the Phase III CLEAR trial (KEYNOTE-581/Study 307) of its checkpoint inhibitor Keytruda (pembrolizumab) and Eisai’s tyrosine kinase inhibitor Lenvima (lenvatinib) in renal cell carcinoma. The combination of Keytruda and Lenvima was compared to Lenvima plus everolimus versus Pfizer’s Sutent (sunitinib) for first-line treatment of patients with advanced renal cell carcinoma (RCC). The combination of Keytruda and Lenvima demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared to sunitinib. The Lenvima-everolimus combination also demonstrated statistically significant improvements in PFS and ORR compared to sunitinib. In exploratory analysis, the data for PFS and OS were consistent across prespecified Memorial Sloan Kettering Cancer Center (MSKCC) risk groups, in other words, favorable, intermediate, and poor. bluebird bio announced that it has placed its Phase I/II and Phase III trial of LentiGlobin gene therapy for sickle cell disease (SCD) on temporary suspension. The cause is a Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML). HGB-206 is the company’s ongoing Phase I/II trial of LentiGlobin for SCD. It includes three cohorts, A, B and C. In Group C, a refined manufacturing process designed to increase vector copy number was used. Group C also received LentiGlobin for SCD manufactured from hematopoietic (blood) stem cells (HSCs) collected from peripheral blood after mobilization with plerixafor, instead of by way of bone marrow harvest, which was the method used in Groups A and B. HGB-210 is their ongoing Phase III single-arm open-label trial. It is evaluating efficacy and safety of LentiGlobin for SCD in patients between two years and 50 years of age with sickle cell disease. Histogen announced week 26 results from its Phase Ib/IIa trial of HST-001 in male patients with androgenic alopecia—hair loss. At the timepoint, patients receiving the drug demonstrated statistically significant change from baseline in total hairs in the target area. HST-001, or Hair Stimulating Complex (HSC), is designed to be a physician-administered treatment for hair loss. Recce Pharmaceuticals formalized a deal with Fiona Stanley Hospital in Australia for a Phase I/II trial of RECCE 327, its new spray-on, broad-spectrum antibiotic for topical burn wound infections. It will enroll up to 30 patients. Eli Lilly announced results from its SURPASS-3 and SURPASS-5 Phase III trials after 52 weeks and 40 weeks, respectively. SURPASS-3 compared tirzepatide to titrated insulin degludec and SURPASS-5 compared tirzepatide to placebo, both as an add-on to titrated insulin glargine. All primary and all key secondary endpoints were met. Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist being evaluated for type 2 diabetes. The drug significantly reduced A1C and body weight in type 2 diabetes. Selecta Biosciences and AskBio initiated first-in-human dose escalation Phase I trial of SEL-399. SEL-399 is an AAV serotype 8 empty vector capsid containing no DNA combined with ImmTOR. The trial is to determine the optimal dose of ImmTOR to mitigate the formation of antibodies to AAV8 capsids used in gene therapies. Salarius Pharmaceuticals completed the dose-escalation stage and established the recommended Phase II dose for its ongoing Phase I/II trial for seclidemstat in r/r Ewing sarcoma. Seclidemstat is a novel, oral reversible inhibitor of the lysine-specific histone demethylase 1 enzyme (LSD1), which plays a key role in the development and progression of certain cancers. AstraZeneca and Merck announced the OlympiA Phase III trial for Lynparza (Olaparib) will move to early primary analysis and reporting after a recommendation from the Independent Data Monitoring Committee (IDMC). The IDMC decided the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) and demonstrated a sustainable, clinically relevant treatment effect for Lynparza compared to placebo for patients with germline BRCA-mutated high-risk HER2-negative early breast cancer. Ocuphire Pharma initiated enrollment in its Phase II VEGA-1 trial of a combination kit of Nyxol and low-dose pilocarpine in presbyopia. Nyxol is believed to improve near vision based on its ability to reduce pupil diameter, which results in increased depth of field. Dermavant Sciences announced positive safety and efficacy data from a planned interim analysis of PSOARING 3 of tapinarof in adults with plaque psoriasis. Tapinarof is a novel, once-daily aryl hydrocarbon receptor modulating agent (TAMA). Flexion Therapeutics announced plans to advance FX201 into the high dose cohort of the Phase I trial. FX201 is an intra-articular, IL-1Ra gene therapy product for osteoarthritis. ChemoCentryx published data from its Phase III ADVOCATE trial of avacopan in patients with anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis). Avacopan is an oral selective complement 51 receptor inhibitor. Treatment with avacopan in the absence of daily oral prednisone led to remission at week 26 and superiority in sustaining remission at 52 weeks compared to the prednisone group. vTv Therapeutics initiated its Phase I trial of orally administered phosphodiesterase type 4 inhibitor, HPP737 in healthy adults. The drug is being developed for the treatment of psoriasis. Most Read Today